Medical Device Manufacturer · US , Walker , MI

Diagnostic Reagents, Inc.

66 submissions · 66 cleared · Since 1982
66
Total
66
Cleared
0
Denied

Diagnostic Reagents, Inc. — FDA 510(k) Submissions

Diagnostic Reagents, Inc. has submitted 66 FDA 510(k) premarket notifications since 1982, of which 66 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrators, Drug Specific, Calibrators, Drug Mixture, Enzyme Immunoassay, Phencyclidine, Enzyme Immunoassay, Barbiturate, Enzyme Immunoassay, Cocaine And Cocaine Metabolites . Use the specialty filter in the sidebar to narrow results.

66 devices
1–25 of 66
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
K983268 · LFH U.v. Spectrometry,... · Toxicology
Nov 1998 62d
NAPA EIA ASSAY
K983812 · LAN Enzyme Immunoassay,... · Toxicology
Nov 1998 19d
DIGOXIN IMMUNOASSAY
K983323 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Nov 1998 51d
VANCOMYCIN EIA ASSAY
K983280 · LEH Radioimmunoassay, Vancomycin · Toxicology
Nov 1998 49d
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
K983159 · DKB Calibrators, Drug Mixture · Toxicology
Nov 1998 57d
LIDOCAINE EIA ASSAY
K973102 · KLR Enzyme Immunoassay,... · Toxicology
Sep 1997 24d
50NG/ML COCAINE METABOLITE CALIBRATOR
K972835 · DLJ Calibrators, Drug Specific · Toxicology
Aug 1997 28d
METHADONE EIA ASSAY
K972526 · DJR Enzyme Immunoassay,... · Toxicology
Aug 1997 39d
QUINIDINE ENZYME IMMUNOASSAY
K964212 · LBZ Enzyme Immunoassay,... · Toxicology
Dec 1996 57d
DIGOXIN ENZYME IMMUNOASSAY
K963835 · KXT Enzyme Immunoassay, Digoxin · Toxicology
Dec 1996 77d
PROCAINAMIDE ENZYME IMMUNOASSAY
K962463 · LAR Enzyme Immunoassay,... · Toxicology
Aug 1996 50d
VALPROIC ACID EIA TEST
K961988 · LEG Enzyme Immunoassay,... · Toxicology
Jul 1996 56d
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · LDP Colorimetry, Acetaminophen · Toxicology
Jul 1996 90d
TRICYCLICS SERUM TOX ASSAY
K961393 · LFH U.v. Spectrometry,... · Toxicology
Jun 1996 62d
BENZODIAZEPINE SERUM TOX EIA TEST
K960708 · JXM Enzyme Immunoassay,... · Toxicology
May 1996 89d
AED CALIBRATORS
K961273 · DKB Calibrators, Drug Mixture · Toxicology
May 1996 43d
BARBITURATE SERUM TOX EIA ASSAY
K960664 · DIS Enzyme Immunoassay,... · Toxicology
May 1996 80d
SERUM TOX CALIBRATOR
K961372 · DKB Calibrators, Drug Mixture · Toxicology
May 1996 22d
SALICYLATE ASSAY
K961131 · DKJ Colorimetry, Salicylate · Toxicology
Apr 1996 39d
COCAINE METABOLITE EIA TEST
K960187 · DIO Enzyme Immunoassay,... · Toxicology
Apr 1996 77d
PRIMIDONE EIA TEST
K960526 · DJP Radioimmunoassay,... · Toxicology
Mar 1996 41d
BARBITURATE EIA ESSAY (MODIFICATION)
K955928 · DIS Enzyme Immunoassay,... · Toxicology
Mar 1996 84d
CARBAMAZEPINE EIA TEST
K955100 · KLT Enzyme Immunoassay,... · Toxicology
Dec 1995 35d
PH-DETECT TEST
K952178 · JQY Ph Meter · Chemistry
Oct 1995 164d
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596 · KLS Enzyme Immunoassay,... · Toxicology
Aug 1995 66d
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