Home / Companies / Diagnostic Reagents, Inc.

Diagnostic Reagents, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
66
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYNovember 18, 1998
K983812NAPA EIA ASSAYNovember 16, 1998
K983323DIGOXIN IMMUNOASSAYNovember 12, 1998
K983280VANCOMYCIN EIA ASSAYNovember 6, 1998
K983159DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSNovember 5, 1998
K973102LIDOCAINE EIA ASSAYSeptember 12, 1997
K97283550NG/ML COCAINE METABOLITE CALIBRATORAugust 28, 1997
K972526METHADONE EIA ASSAYAugust 4, 1997
K964212QUINIDINE ENZYME IMMUNOASSAYDecember 18, 1996
K963835DIGOXIN ENZYME IMMUNOASSAYDecember 10, 1996
K962463PROCAINAMIDE ENZYME IMMUNOASSAYAugust 14, 1996
K961988VALPROIC ACID EIA TESTJuly 16, 1996
K961373ACETAMINOPHEN SERUM TOX EIA ASSAYJuly 8, 1996
K961393TRICYCLICS SERUM TOX ASSAYJune 12, 1996
K960708BENZODIAZEPINE SERUM TOX EIA TESTMay 20, 1996
K961273AED CALIBRATORSMay 15, 1996
K960664BARBITURATE SERUM TOX EIA ASSAYMay 6, 1996
K961372SERUM TOX CALIBRATORMay 1, 1996
K961131SALICYLATE ASSAYApril 29, 1996
K960187COCAINE METABOLITE EIA TESTApril 2, 1996