FDA 510(k) Applications Submitted by YUH-GENG TSAY, PH.D.

FDA 510(k) Number Submission Date Device Name Applicant
K960187 01/16/1996 COCAINE METABOLITE EIA TEST DIAGNOSTIC REAGENTS, INC.
K960526 02/06/1996 PRIMIDONE EIA TEST DIAGNOSTIC REAGENTS, INC.
K960708 02/21/1996 BENZODIAZEPINE SERUM TOX EIA TEST DIAGNOSTIC REAGENTS, INC.
K961273 04/02/1996 AED CALIBRATORS DIAGNOSTIC REAGENTS, INC.
K961372 04/09/1996 SERUM TOX CALIBRATOR DIAGNOSTIC REAGENTS, INC.
K961373 04/09/1996 ACETAMINOPHEN SERUM TOX EIA ASSAY DIAGNOSTIC REAGENTS, INC.
K972526 06/26/1997 METHADONE EIA ASSAY DIAGNOSTIC REAGENTS, INC.
K972835 07/31/1997 50NG/ML COCAINE METABOLITE CALIBRATOR DIAGNOSTIC REAGENTS, INC.
K973102 08/19/1997 LIDOCAINE EIA ASSAY DIAGNOSTIC REAGENTS, INC.
K983159 09/09/1998 DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS DIAGNOSTIC REAGENTS, INC.
K983268 09/17/1998 MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY DIAGNOSTIC REAGENTS, INC.
K983280 09/18/1998 VANCOMYCIN EIA ASSAY DIAGNOSTIC REAGENTS, INC.
K983323 09/22/1998 DIGOXIN IMMUNOASSAY DIAGNOSTIC REAGENTS, INC.
K963835 09/24/1996 DIGOXIN ENZYME IMMUNOASSAY DIAGNOSTIC REAGENTS, INC.
K964212 10/22/1996 QUINIDINE ENZYME IMMUNOASSAY DIAGNOSTIC REAGENTS, INC.
K983812 10/28/1998 NAPA EIA ASSAY DIAGNOSTIC REAGENTS, INC.
K955928 12/18/1995 BARBITURATE EIA ESSAY (MODIFICATION) DIAGNOSTIC REAGENTS, INC.
K961131 03/21/1996 SALICYLATE ASSAY DIAGNOSTIC REAGENTS, INC.
K961393 04/11/1996 TRICYCLICS SERUM TOX ASSAY DIAGNOSTIC REAGENTS, INC.
K962463 06/25/1996 PROCAINAMIDE ENZYME IMMUNOASSAY DIAGNOSTIC REAGENTS, INC.


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