Siemens Healthcare Diagnostics Products GmbH - FDA 510(k) Cleared Dev...
19
Total
18
Cleared
1
Denied
Siemens Healthcare Diagnostics Products GmbH has 18 FDA 510(k) cleared medical devices. Based in Marburg, DE.
Latest FDA clearance: Oct 2024. Active since 2016. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Siemens Healthcare Diagnostics Products GmbH Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Siemens Healthcare Diagnostics...
19 devices
Cleared
Oct 10, 2024
INNOVANCE Anti-Xa (OPPU05)
Hematology
251d
Cleared
Dec 13, 2023
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Immunology
28d
Cleared
Jun 02, 2023
vWF Ag
Hematology
445d
Cleared
Dec 16, 2022
CardioPhase® hsCRP
Chemistry
490d
Not Cleared
Sep 29, 2022
INNOVANCE VWF Ac
Hematology
701d
Cleared
Mar 02, 2022
N Latex FLC kappa, N Latex FLC lambda
Immunology
212d
Cleared
Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
Immunology
511d
Cleared
Jul 14, 2021
N Latex FLC kappa, N Latex FLC lambda
Immunology
621d
Cleared
May 03, 2019
N Latex FLC kappa, N Latex FLC lambda
Immunology
29d
Cleared
Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
Immunology
90d
Cleared
Sep 07, 2018
INNOVANCE Free PS Ag
Hematology
88d
Cleared
Nov 17, 2017
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC...
Immunology
158d