Medical Device Manufacturer · US , Fremont Blvd. , CA

Microgenics Corporation

21 submissions · 20 cleared · Since 2009
21
Total
20
Cleared
1
Denied

Microgenics Corporation — FDA 510(k) Submissions

Microgenics Corporation has submitted 21 FDA 510(k) premarket notifications since 2009, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Benzodiazepine, Enzyme Immunoassay, Cocaine And Cocaine Metabolites, U.v. Spectrometry, Tricyclic Antidepressant Drugs, Multi-analyte Controls, All Kinds (assayed) . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
Alinity c Benzodiazepines Reagent Kit
K243498 · JXM Enzyme Immunoassay,... · Toxicology
Dec 2024 29d
DRI Ecstasy Plus Assay
K240670 · DKZ Enzyme Immunoassay,... · Toxicology
Oct 2024 233d
Alinity c Tricyclic Antidepressants Reagent Kit
K231020 · LFH U.v. Spectrometry,... · Toxicology
Nov 2023 221d
CEDIA Heroin Metabolite (6-AM) Assay
K231007 · DJG Enzyme Immunoassay, Opiates · Chemistry
Sep 2023 173d
DRI TM Tricyclics Serum Tox Assay
K213875 · LFH U.v. Spectrometry,... · Toxicology
Dec 2022 373d
DRI Cocaine Metabolite Assay
K211973 · DIO Enzyme Immunoassay,... · Toxicology
Sep 2021 91d
CEDIA Heroin Metabolite (6-AM) assay
K192943 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 2019 59d
CEDIA Benzodiazepine Assay
K190968 · JXM Enzyme Immunoassay,... · Toxicology
Dec 2019 241d
QMS Plazomicin Immunoassay
DEN180030 · QDR Plazomicin Test System,... · Toxicology
Nov 2018 147d
DRI Cocaine Metabolite Assay
K181499 · DIO Enzyme Immunoassay,... · Toxicology
Jul 2018 29d
DRI Benzodiazepine Assay
K173963 · JXM Enzyme Immunoassay,... · Toxicology
Feb 2018 55d
DRI Hydrocodone Assay
K173195 · DJG Enzyme Immunoassay, Opiates · Toxicology
Feb 2018 134d
CEDIA Heroin Metabolite (6-AM) Assay
K173183 · DJG Enzyme Immunoassay, Opiates · Toxicology
Nov 2017 51d
CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set
K163101 · DJG Enzyme Immunoassay, Opiates · Toxicology
Apr 2017 150d
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
K150502 · DJG Enzyme Immunoassay, Opiates · Chemistry
Oct 2015 225d
ABBOTT CARBAMAZEPINE ASSAY
K123518 · KLT Enzyme Immunoassay,... · Toxicology
Jun 2013 203d
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
K120936 · DKB Calibrators, Drug Mixture · Toxicology
Dec 2012 260d
THERMO SCIENTIFIC MAS OMNI-CARDIO
K122291 · JJY Multi-analyte Controls,... · Chemistry
Aug 2012 31d
THERMO SCIENTIFIC MAS OMNI-CORE
K110738 · JJY Multi-analyte Controls,... · Chemistry
Nov 2011 231d
THERMO SCIENTIFIC MAS R DOA TOTAL
K103656 · DIF Drug Mixture Control... · Toxicology
Mar 2011 99d
MAS AND MINI-TROL PTH CONTROL
K092749 · JJX Single (specified)... · Immunology
Dec 2009 86d
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