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

Total

Cleared

Denied

Microgenics Corporation has 20 FDA 510(k) cleared toxicology devices. Based in Fremont Blvd., US.

Latest FDA clearance: Dec 2024. Active since 2009.

Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Thermo Fisher Scientific as regulatory consultant.

Microgenics Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Microgenics Corporation

21 devices

1-21 of 21

Cleared Dec 11, 2024

Alinity c Benzodiazepines Reagent Kit

K243498 · JXM

Toxicology · 29d

Cleared Oct 30, 2024

DRI Ecstasy Plus Assay

K240670 · DKZ

Toxicology · 233d

Cleared Nov 17, 2023

Alinity c Tricyclic Antidepressants Reagent Kit

K231020 · LFH

Toxicology · 221d

Cleared Sep 27, 2023

CEDIA Heroin Metabolite (6-AM) Assay

K231007 · DJG

Chemistry · 173d

Cleared Dec 21, 2022

DRI TM Tricyclics Serum Tox Assay

K213875 · LFH

Toxicology · 373d

Cleared Sep 24, 2021

DRI Cocaine Metabolite Assay

K211973 · DIO

Toxicology · 91d

Cleared Dec 16, 2019

CEDIA Heroin Metabolite (6-AM) assay

K192943 · DJG

Toxicology · 59d

Cleared Dec 09, 2019

CEDIA Benzodiazepine Assay

K190968 · JXM

Toxicology · 241d

Not Cleared Nov 19, 2018

QMS Plazomicin Immunoassay

DEN180030 · QDR

Toxicology · 147d

Cleared Jul 06, 2018

DRI Cocaine Metabolite Assay

K181499 · DIO

Toxicology · 29d

Cleared Feb 21, 2018

DRI Benzodiazepine Assay

K173963 · JXM

Toxicology · 55d

Cleared Feb 13, 2018

DRI Hydrocodone Assay

K173195 · DJG

Toxicology · 134d

Cleared Nov 22, 2017

CEDIA Heroin Metabolite (6-AM) Assay

K173183 · DJG

Toxicology · 51d

Cleared Apr 06, 2017

CEDIA Buprenorphine II Assay

K163101 · DJG

Toxicology · 150d

Cleared Oct 09, 2015

DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls

K150502 · DJG

Chemistry · 225d

Cleared Jun 05, 2013

ABBOTT CARBAMAZEPINE ASSAY

K123518 · KLT

Toxicology · 203d

Cleared Dec 13, 2012

ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS...

K120936 · DKB

Toxicology · 260d

Cleared Aug 31, 2012

THERMO SCIENTIFIC MAS OMNI-CARDIO

K122291 · JJY

Chemistry · 31d

Cleared Nov 03, 2011

THERMO SCIENTIFIC MAS OMNI-CORE

K110738 · JJY

Chemistry · 231d

Cleared Mar 24, 2011

THERMO SCIENTIFIC MAS R DOA TOTAL

K103656 · DIF

Toxicology · 99d

Cleared Dec 03, 2009

MAS AND MINI-TROL PTH CONTROL

K092749 · JJX

Immunology · 86d

Microgenics Corporation - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Microgenics Corporation

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