FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K832419 |
ABBOTT LABORATORIES |
A-GENT PHERYTOIN |
09/01/1983 |
K080696 |
ABBOTT LABORATORIES |
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 |
09/11/2008 |
K833806 |
ABBOTT LABORATORIES |
CHEMKIT PHENYTOIN DIAG. KIT |
01/30/1984 |
K896074 |
ABBOTT LABORATORIES |
VISION PHENYTOIN |
11/17/1989 |
K860286 |
ALLIED INSTRUMENTATION LABORATORY |
IL TEST PHENYTOIN |
03/05/1986 |
K932686 |
BAXTER DIAGNOSTICS, INC. |
PARAMAX(R) PHENYTOIN REAGENT |
11/26/1993 |
K915755 |
BIOTRACK, INC. |
BIOTRACK PHENYTOIN TEST CARTRIDGE |
07/23/1992 |
K963840 |
BOEHRINGER MANNHEIM CORP. |
CEDIA PHENYTOIN II ASSAY |
11/20/1996 |
K860048 |
CLINICAL DATA, INC. |
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN) |
01/22/1986 |
K000006 |
DIAGNOSTIC PRODUCTS CORP. |
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 |
02/28/2000 |
K945725 |
DIAGNOSTIC REAGENTS, INC. |
PHENYTION EIA TEST |
02/03/1995 |
K911056 |
E.I. DUPONT DE NEMOURS & CO., INC. |
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD |
04/03/1991 |
K843209 |
E.I. DUPONT DE NEMOURS & CO., INC. |
PHENYTOIN ACA ANALYTICAL TEST PACK |
10/11/1984 |
K771233 |
E.I. DUPONT DE NEMOURS & CO., INC. |
PHENYTOIN ANALYTICAL TEST PACKS |
07/15/1977 |
K941142 |
EASTMAN KODAK COMPANY |
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN |
06/13/1994 |
K811745 |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
VIRGO IPA FOR DETECTION OF PHENYTOIN |
07/10/1981 |
K862349 |
EM DIAGNOSTIC SYSTEMS, INC. |
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 |
07/07/1986 |
K864554 |
EM DIAGNOSTIC SYSTEMS, INC. |
EASY-TEST PRIMIDONE ITEM NO. 67---/95 |
01/07/1987 |
K864925 |
EM DIAGNOSTIC SYSTEMS, INC. |
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 |
01/07/1987 |
K901080 |
IMMUNOTECH CORP. |
EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT |
05/17/1990 |
K902952 |
INSTRUMENTATION LABORATORY CO. |
IL PHENYTOIN ASSAY SYSTEM |
08/22/1990 |
K943980 |
INSTRUMENTATION LABORATORY CO. |
IL TEST PHENYTION CALIBRATORS |
05/01/1995 |
K905689 |
MICROGENICS CORP. |
CEDIA PHENYTOIN ASSAY |
01/17/1991 |
K842092 |
MILES LABORATORIES, INC. |
SERALYZER ARIS PHENYTOIN REAGENT STRIPS |
03/19/1985 |
K011393 |
RANDOX LABORATORIES, LTD. |
RANDOX PHENYTOIN |
12/04/2001 |
K030428 |
ROCHE DIAGNOSTICS CORP. |
ROCHE ONLINE TDM PHENYTOIN |
04/28/2003 |
K973414 |
SCHIAPPARELLI BIOSYSTEMS, INC. |
ACE PHENYTOIN REAGENT, AED CALIBRATORS |
11/04/1997 |
K944085 |
SCHIAPPARELLI BIOSYSTEMS, INC. |
ACE(TM) CEDIA(R) PHENYTOIN ASSAY |
12/28/1994 |
K904815 |
SERADYN, INC. |
QMS TM- PHENYTOIN |
11/06/1990 |
K870953 |
SIGMA DIAGNOSTICS, INC. |
PHENYTOIN FPIA REAGENT SET |
03/31/1987 |
K855026 |
SYVA / A SYNTEX CO. |
ACCULEVEL PHENYTOIN TEST |
08/25/1986 |
K993026 |
SYVA CO. |
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS |
01/27/2000 |
K780218 |
SYVA CO. |
ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE |
03/03/1978 |
K011347 |
SYVA CO. |
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 |
05/17/2001 |
K832033 |
SYVA CO. |
EMIT AED PHENYTOIN ASSAY |
08/01/1983 |
K772179 |
SYVA CO. |
EMIT ANTIEPILEPTIC DRUG ASSAYS |
12/20/1977 |
K874856 |
SYVA CO. |
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY |
01/05/1988 |
K844991 |
SYVA CO. |
EMIT PHENYTOIN ASSAY |
01/23/1985 |
K834406 |
SYVA CO. |
EMIT QST PHENYTOIN ASSAY |
02/03/1984 |
K850712 |
SYVA CO. |
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY |
03/20/1985 |
K913429 |
SYVA CO. |
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS |
08/26/1991 |
K863403 |
TECHNICON INSTRUMENTS CORP. |
PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS |
09/29/1986 |
K063145 |
THERMO ELECTRON OY |
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS |
10/17/2007 |
K842161 |
VENTREX LABORATORIES, INC. |
VENTREZYME PHENYTOIN KIT IMMUNOASSAY |
07/09/1984 |