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Diagnostic Reagents, Inc.

FDA 510(k) & PMA Approved Devices — 66 products

Total Devices66
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K983268 MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYLFH1998-11-18 View
510(k) K983812 NAPA EIA ASSAYLAN1998-11-16 View
510(k) K983323 DIGOXIN IMMUNOASSAYKXT1998-11-12 View
510(k) K983280 VANCOMYCIN EIA ASSAYLEH1998-11-06 View
510(k) K983159 DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLSDKB1998-11-05 View
510(k) K973102 LIDOCAINE EIA ASSAYKLR1997-09-12 View
510(k) K972835 50NG/ML COCAINE METABOLITE CALIBRATORDLJ1997-08-28 View
510(k) K972526 METHADONE EIA ASSAYDJR1997-08-04 View
510(k) K964212 QUINIDINE ENZYME IMMUNOASSAYLBZ1996-12-18 View
510(k) K963835 DIGOXIN ENZYME IMMUNOASSAYKXT1996-12-10 View
510(k) K962463 PROCAINAMIDE ENZYME IMMUNOASSAYLAR1996-08-14 View
510(k) K961988 VALPROIC ACID EIA TESTLEG1996-07-16 View
510(k) K961373 ACETAMINOPHEN SERUM TOX EIA ASSAYLDP1996-07-08 View
510(k) K961393 TRICYCLICS SERUM TOX ASSAYLFH1996-06-12 View
510(k) K960708 BENZODIAZEPINE SERUM TOX EIA TESTJXM1996-05-20 View
510(k) K961273 AED CALIBRATORSDKB1996-05-15 View
510(k) K960664 BARBITURATE SERUM TOX EIA ASSAYDIS1996-05-06 View
510(k) K961372 SERUM TOX CALIBRATORDKB1996-05-01 View
510(k) K961131 SALICYLATE ASSAYDKJ1996-04-29 View
510(k) K960187 COCAINE METABOLITE EIA TESTDIO1996-04-02 View
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