Siemens Healthcare Diagnostics Products GmbH FDA Approvals

0 new drug approvals and 8 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
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)510(k)Oct 10, 2024Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Oct 10, 2024
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)510(k)Dec 13, 2023Immunology	Immunology	510(k)Substantially Equivalent (Special)	Dec 13, 2023
vWF Ag510(k)Jun 2, 2023Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Jun 2, 2023
CardioPhase® hsCRP510(k)Dec 16, 2022Immunology	Immunology	510(k)Substantially Equivalent (Special)	Dec 16, 2022
INNOVANCE VWF Ac510(k)Sep 29, 2022Hematology	Hematology	510(k)Unknown (Direct)	Sep 29, 2022
N Latex FLC kappa, N Latex FLC lambda510(k)Mar 2, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Mar 2, 2022
N Latex FLC kappa, N Latex FLC lambda510(k)Oct 29, 2021Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda510(k)Jul 14, 2021Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Jul 14, 2021