Roche Diagnostics FDA Approvals

0 new drug approvals and 39 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Elecsys Phospho-Tau (217P) Plasma510(k)Aug 19, 2026Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Aug 19, 2026
cobas pulse blood glucose monitoring system510(k)Jun 12, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Dual Track)	Jun 12, 2026
Elecsys Anti-SARS-CoV-2 S510(k)Apr 13, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 13, 2026
Elecsys Anti-HBc IgM510(k)Apr 7, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 7, 2026
Elecsys Anti-HAV IgM510(k)Apr 7, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 7, 2026
Elecsys Anti-HBc II510(k)Apr 7, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 7, 2026
Tina-quant Cardiac high sensitivity CRP III510(k)Apr 2, 2026Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Apr 2, 2026
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions510(k)Feb 12, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Feb 12, 2026
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions510(k)Feb 12, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Feb 12, 2026
Elecsys Anti-SARS-CoV-2510(k)Dec 17, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Dec 17, 2025
CoaguChek XS Plus System510(k)Oct 24, 2025Hematology	Hematology	510(k)Substantially Equivalent (Special)	Oct 24, 2025
Elecsys Phospho-Tau (181P) Plasma510(k)Oct 8, 2025Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Oct 8, 2025
Elecsys Cortisol III510(k)Jul 17, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 17, 2025
Elecsys Anti-SARS-CoV-2510(k)Jun 10, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2025
Elecsys sFlt-1 and Elecsys PlGF510(k)Feb 7, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Feb 7, 2025
Elecsys Folate III510(k)Jun 17, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jun 17, 2024
cobas pulse blood glucose monitoring system510(k)Apr 26, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Dual Track)	Apr 26, 2024
Elecsys PTH , Elecsys PTH STAT510(k)Mar 22, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Mar 22, 2024
Elecsys Tg II510(k)Sep 30, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 30, 2023
Elecsys Anti-Tg510(k)Sep 15, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 15, 2023
Elecsys proBNP II, Elecsys proBNP II STAT510(k)Jul 21, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 21, 2023
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF510(k)Jun 5, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Jun 5, 2023
Elecsys FT4 IV510(k)Apr 7, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 7, 2023
ONLINE TDM Phenytoin - Free Phenytoin application510(k)Mar 30, 2023Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Mar 30, 2023
Elecsys Anti-HCV II (08837031190)510(k)Jan 4, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 4, 2023
ONLINE DAT Benzodiazepines II510(k)Dec 23, 2022Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Dec 23, 2022
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF510(k)Dec 7, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Dec 7, 2022
Elecsys HSV-2 IgG (08948887160)510(k)Oct 12, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 12, 2022
Elecsys CMV IgG510(k)Oct 12, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)510(k)Oct 12, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Oct 12, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH510(k)Sep 16, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Sep 16, 2022
Elecsys AFP510(k)Sep 15, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 15, 2022
Elecsys AMH510(k)Jun 10, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jun 10, 2022
Elecsys Testosterone II510(k)May 6, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 6, 2022
Elecsys proBNP II, Elecsys proBNP II STAT510(k)Mar 31, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Mar 31, 2022
Elecsys Troponin T Gen 5510(k)Sep 21, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Sep 21, 2021
Elecsys Vitamin D total III510(k)Sep 1, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Sep 1, 2021
Elecsys HCG STAT510(k)Aug 18, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 18, 2021
Elecsys Syphilis510(k)Jul 20, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 20, 2021

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