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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