Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
152
Total
151
Cleared
1
Denied
FDA 510(k) cleared devices by Siemens Healthcare Diagnostics, Inc. Toxicology ✕
12 devices
Cleared
Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
Toxicology
361d
Cleared
Jul 25, 2023
Emit® II Plus Buprenorphine Assay
Toxicology
418d
Cleared
Jun 02, 2023
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
Toxicology
346d
Cleared
Jul 16, 2021
ADVIA Centaur® Digoxin assay
Toxicology
588d
Cleared
Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
Toxicology
267d
Cleared
Oct 18, 2017
Emit II Plus Oxycodone Assay
Toxicology
23d
Cleared
Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
Toxicology
141d
Cleared
Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
Toxicology
90d
Cleared
Oct 23, 2015
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug...
Toxicology
227d
Cleared
Oct 30, 2008
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR,...
Toxicology
121d
Cleared
Aug 22, 2008
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
Toxicology
36d
Cleared
Aug 05, 2008
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
Toxicology
22d