Medical Device Manufacturer · US , Fremont Blvd. , CA

Microgenics Corporation - FDA 510(k) Cleared Devices

21 submissions · 20 cleared · Since 2009

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

1-12 of 16

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

DEN180030 · QDR

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