Medical Device Manufacturer · US , Concord , CA

Microgenics Corp.

107 submissions · 106 cleared · Since 1985
107
Total
106
Cleared
1
Denied

Microgenics Corp. — FDA 510(k) Submissions

Microgenics Corp. has submitted 107 FDA 510(k) premarket notifications since 1985, of which 106 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Digoxin, Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Amphetamine, Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine, Enzyme Immunoassay, Cannabinoids . Use the specialty filter in the sidebar to narrow results.

107 devices
1–25 of 107
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
K122766 · OUF Everolimus Immunoassay · Chemistry
Aug 2013 344d
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · MLM Enzyme Immunoassay,... · Toxicology
Jul 2013 253d
ABBOTT PHENOBARBITAL ASSAY
K123271 · DLZ Enzyme Immunoassay,... · Chemistry
Apr 2013 189d
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
K110616 · JJY Multi-analyte Controls,... · Chemistry
Jun 2011 118d
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K101742 · DIO Enzyme Immunoassay,... · Toxicology
Apr 2011 290d
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
K101744 · LDJ Enzyme Immunoassay,... · Chemistry
Apr 2011 290d
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
K101745 · DKZ Enzyme Immunoassay,... · Chemistry
Apr 2011 290d
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
K101746 · LCM Enzyme Immunoassay,... · Chemistry
Apr 2011 290d
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
K101752 · DKB Calibrators, Drug Mixture · Chemistry
Apr 2011 290d
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
K101753 · LAF Gas Chromatography,... · Chemistry
Apr 2011 290d
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
K101754 · DJG Enzyme Immunoassay, Opiates · Toxicology
Apr 2011 290d
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
K100144 · OUF Everolimus Immunoassay · Chemistry
Feb 2011 388d
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · DKZ Enzyme Immunoassay,... · Chemistry
May 2010 223d
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
K092051 · JJY Multi-analyte Controls,... · Chemistry
Sep 2009 76d
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
K090810 · GKZ Counter, Differential Cell · Hematology
Sep 2009 177d
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
K061196 · JJY Multi-analyte Controls,... · Chemistry
May 2006 32d
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · LCP Assay, Glycosylated... · Chemistry
Feb 2006 58d
MAS IMMUNOSUPPRESSANT CONTROLS
K051074 · LAS Drug Specific Control... · Toxicology
Jun 2005 40d
CEDIA TACROLIMUS ASSAY
K050206 · MLM Enzyme Immunoassay,... · Toxicology
Mar 2005 46d
CEDIA SIROLIMUS ASSAY
DEN040008 · NRP Sirolimus Test System · Chemistry
Jul 2004 41d
CEDIA BUPRENORPHINE ASSAY
K040316 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jun 2004 135d
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
K040758 · DIF Drug Mixture Control... · Toxicology
May 2004 64d
DRI OXYCODONE ASSAY
K040411 · LAS Drug Specific Control... · Toxicology
May 2004 99d
DOCUMENT SALICYLATE CAL VER
K041073 · JJY Multi-analyte Controls,... · Chemistry
May 2004 25d
CEDIA VANCOMYCIN ASSAY
K032811 · LEH Radioimmunoassay, Vancomycin · Toxicology
Nov 2003 76d

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