Medical Device Manufacturer · US , Concord , CA

Microgenics Corp. - FDA 510(k) Cleared Devices

107 submissions · 106 cleared · Since 1985
107
Total
106
Cleared
1
Denied
107 devices
51-75 of 107
Cleared Jan 17, 1995
CEDIA(R) DAU PCP ASSAY
K946059 · LCM
Toxicology · 36d
Cleared Jan 17, 1995
CEDIA(R) FOLATE (NO BOIL) ASSAY
K946184 · CGN
Chemistry · 28d
Cleared Dec 28, 1994
CEDIA DAU BARBITURATE ASSAY
K945344 · DIS
Toxicology · 57d
Cleared Nov 02, 1994
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
K944562 · LDJ
Chemistry · 64d
Cleared Oct 21, 1994
CEDIA DAU AMPHETAMINES ASSAY
K943993 · DKZ
Chemistry · 66d
Cleared Oct 20, 1994
CEDIA T4 MAB ASSAY
K943019 · KLI
Chemistry · 118d
Cleared Sep 07, 1994
CEDIA DAU OPIATE ASSAY
K941195 · DJG
Toxicology · 177d
Cleared Aug 30, 1994
CEDIA DAU BARBITURATE ASSAY
K942436 · DIS
Toxicology · 124d
Cleared Aug 24, 1994
MICROGENICS THC CONTROL SETS
K943048 · LAS
Toxicology · 58d
Cleared Aug 01, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337 · LDJ
Toxicology · 77d
Cleared Aug 01, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K942795 · JXM
Toxicology · 54d
Cleared Jul 28, 1994
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404 · DIS
Toxicology · 129d
Cleared Jul 28, 1994
CEDIA T4 MAB ASSAY
K942575 · KLI
Chemistry · 58d
Cleared Jul 20, 1994
CEDIA DAU AMPHETAMINES ASSAY
K941372 · DKZ
Toxicology · 120d
Cleared Jun 13, 1994
CEDIA DIGOXIN PLUS ASSAY
K941255 · KXT
Toxicology · 91d
Cleared Jun 02, 1994
CEDIA DAU COCAINE ASSAY
K941310 · DIO
Toxicology · 80d
Cleared May 27, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K940159 · JXM
Toxicology · 135d
Cleared May 17, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747...
K940649 · LDJ
Toxicology · 91d
Cleared Apr 26, 1994
CEDIA T4 MAB ASSAY
K941042 · KLI
Chemistry · 50d
Cleared Apr 06, 1994
CEDIA DAU THC CALIBRATORS
K935795 · DLJ
Toxicology · 120d
Cleared Apr 05, 1994
CEDIA(R) DAU PCP ASSAY
K935650 · LCM
Toxicology · 133d
Cleared Mar 22, 1994
CEDIA DAU BARBITURATE ASSAY
K936030 · DIS
Toxicology · 95d
Cleared Mar 14, 1994
CEDIA DAU NEGATIVE CALIBRATOR
K935793 · DKB
Toxicology · 97d
Cleared Mar 14, 1994
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
K936028 · DKB
Toxicology · 87d
Cleared Mar 11, 1994
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS
K935904 · DIO
Toxicology · 91d

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