Microgenics Corporation - FDA 510(k) Cleared Devices
Recent clearances: Alinity c Benzodiazepines Reagent Kit, DRI Ecstasy Plus Assay, Alinity c Tricyclic Antidepressants Reagent Kit
21
Total
20
Cleared
1
Denied
FDA 510(k) Regulatory Record - Microgenics Corporation Toxicology ✕
16 devices
Cleared
Dec 11, 2024
Alinity c Benzodiazepines Reagent Kit
Toxicology
29d
Cleared
Oct 30, 2024
DRI Ecstasy Plus Assay
Toxicology
233d
Cleared
Nov 17, 2023
Alinity c Tricyclic Antidepressants Reagent Kit
Toxicology
221d
Cleared
Dec 21, 2022
DRI TM Tricyclics Serum Tox Assay
Toxicology
373d
Cleared
Sep 24, 2021
DRI Cocaine Metabolite Assay
Toxicology
91d
Cleared
Dec 16, 2019
CEDIA Heroin Metabolite (6-AM) assay
Toxicology
59d
Cleared
Dec 09, 2019
CEDIA Benzodiazepine Assay
Toxicology
241d
Not Cleared
Nov 19, 2018
QMS Plazomicin Immunoassay
Toxicology
147d
Cleared
Jul 06, 2018
DRI Cocaine Metabolite Assay
Toxicology
29d
Cleared
Feb 21, 2018
DRI Benzodiazepine Assay
Toxicology
55d
Cleared
Feb 13, 2018
DRI Hydrocodone Assay
Toxicology
134d
Cleared
Nov 22, 2017
CEDIA Heroin Metabolite (6-AM) Assay
Toxicology
51d
Cleared
Apr 06, 2017
CEDIA Buprenorphine II Assay
Toxicology
150d
Cleared
Jun 05, 2013
ABBOTT CARBAMAZEPINE ASSAY
Toxicology
203d
Cleared
Dec 13, 2012
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS...
Toxicology
260d
Cleared
Mar 24, 2011
THERMO SCIENTIFIC MAS R DOA TOTAL
Toxicology
99d