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. |
|
|