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Siemens Healthcare Diagnostics, Inc. FDA Approvals
0 new drug approvals and 28 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 |
|---|
| Atellica IM CA 19-9 II510(k)Aug 10, 2026Immunology |
| Atellica CH Acetaminophen 2 (ACTM)510(k)Jul 24, 2026Clinical Toxicology |
| Atellica CH Diazo Total Bilirubin (D_TBil)510(k)Feb 27, 2026Clinical Chemistry |
| Atellica® IM TSH3-Ultra II (TSH3ULII)510(k)Feb 6, 2026Clinical Chemistry |
| Atellica IM Total PSA II (tPSAII)510(k)Jan 5, 2026Immunology |
| ADVIA Centaur Anti-Thyroglobulin II (aTgII)510(k)Dec 4, 2025Immunology |
| ADVIA Centaur Anti-Thyroid Peroxidase II510(k)Oct 17, 2025Immunology |
| Atellica IM Thyroglobulin (Tg)510(k)Jun 20, 2025Immunology |
| Atellica® CH Creatinine_3 (Crea3)510(k)Dec 4, 2024Clinical Chemistry |
| Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)510(k)Jul 26, 2024Clinical Chemistry |
| Atellica® IM High-Sensitivity Troponin I (TnIH)510(k)Jul 25, 2024Clinical Chemistry |
| ADVIA Centaur® TSH3-Ultra II (TSH3ULII)510(k)Apr 4, 2024Clinical Chemistry |
| Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)510(k)Jan 18, 2024Immunology |
| ADVIA Centaur® NT-proBNPII (PBNPII)510(k)Sep 24, 2023Clinical Chemistry |
| Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)510(k)Aug 8, 2023Clinical Toxicology |
| A-LYTE® Integrated Multisensor (IMT Na K Cl)510(k)Jul 25, 2023Clinical Chemistry |
| Emit® II Plus Buprenorphine Assay510(k)Jul 25, 2023Clinical Toxicology |
| Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)510(k)Jul 13, 2023Clinical Chemistry |
| Atellica® CH Diazo Direct Bilirubin (D_DBil)510(k)Jun 12, 2023Clinical Chemistry |
| ADVIA Centaur® Anti-Müllerian Hormone (AMH)510(k)Jun 2, 2023Clinical Chemistry |
| Atellica® CH Diazo Total Bilirubin (D_TBil)510(k)Mar 20, 2023Clinical Chemistry |
| RCRP Flex reagent cartridge510(k)Mar 17, 2023Immunology |
| Dimension EXL LOCI BRAHMS Procalcitonin (PCT)510(k)Aug 26, 2022Microbiology |
| Atellica CH Enzymatic Creatinine_3 (ECre3)510(k)Nov 24, 2021Clinical Chemistry |
| ADVIA Centaur Enhanced Liver Fibrosis (ELF)510(k)Aug 20, 2021Clinical Chemistry |
| ADVIA Centaur® Digoxin assay510(k)Jul 16, 2021Clinical Toxicology |
| ADVIA Centaur® Total hCG assay510(k)Jul 13, 2021Clinical Chemistry |
| ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay510(k)Jul 2, 2021Clinical Chemistry |