FDA 510(k) Applications for Medical Device Product Code "DIP"
(Enzyme Immunoassay, Diphenylhydantoin)

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


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