Panels › Clinical Toxicology › Product code DIP · Class 2
Enzyme Immunoassay, Diphenylhydantoin
Regulation 862.3350
0510(k)s in 12 months (44 all time)
0recalls in 12 months (11 all time)
10recalls that name a 510(k)
Top companies in DIP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2008 | K080696 | ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 Abbott Laboratories | DIP |
| Oct 17, 2007 | K063145 | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS Thermo Electron OY, FI | DIP |
| Apr 28, 2003 | K030428 | ROCHE ONLINE TDM PHENYTOIN Roche Diagnostics Corp. | DIP |
| Dec 4, 2001 | K011393 | RANDOX PHENYTOIN Randox Laboratories, Ltd., IE | DIP |
| May 17, 2001 | K011347 | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 Syva Co. | DIP |
| Feb 28, 2000 | K000006 | IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 Diagnostic Products Corp. | DIP |
| Jan 27, 2000 | K993026 | ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS Syva Co. | DIP |
| Nov 4, 1997 | K973414 | ACE PHENYTOIN REAGENT, AED CALIBRATORS Schiapparelli Biosystems, Inc. | DIP |
| Nov 20, 1996 | K963840 | CEDIA PHENYTOIN II ASSAY Boehringer Mannheim Corp. | DIP |
| May 1, 1995 | K943980 | IL TEST PHENYTION CALIBRATORS Instrumentation Laboratory CO | DIP |
| Feb 3, 1995 | K945725 | PHENYTION EIA TEST Diagnostic Reagents, Inc. | DIP |
| Dec 28, 1994 | K944085 | ACE(TM) CEDIA(R) PHENYTOIN ASSAY Schiapparelli Biosystems, Inc. | DIP |
| Jun 13, 1994 | K941142 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN Eastman Kodak Company | DIP |
| Nov 26, 1993 | K932686 | PARAMAX(R) PHENYTOIN REAGENT Baxter Diagnostics, Inc. | DIP |
| Jul 23, 1992 | K915755 | BIOTRACK PHENYTOIN TEST CARTRIDGE Biotrack, Inc. | DIP |
| Aug 26, 1991 | K913429 | EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS Syva Co. | DIP |
| Apr 3, 1991 | K911056 | DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD E.I. Dupont DE Nemours & Co., Inc. | DIP |
| Jan 17, 1991 | K905689 | CEDIA PHENYTOIN ASSAY Microgenics Corp. | DIP |
| Nov 6, 1990 | K904815 | QMS TM- PHENYTOIN Seradyn, Inc. | DIP |
| Aug 22, 1990 | K902952 | IL PHENYTOIN ASSAY SYSTEM Instrumentation Laboratory CO | DIP |
| May 17, 1990 | K901080 | EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT Immunotech Corp. | DIP |
| Nov 17, 1989 | K896074 | VISION PHENYTOIN Abbott Laboratories | DIP |
| Jan 5, 1988 | K874856 | EMIT CONVENIENCE PACK: PHENYTOIN ASSAY Syva Co. | DIP |
| Mar 31, 1987 | K870953 | PHENYTOIN FPIA REAGENT SET Sigma Diagnostics, Inc. | DIP |
| Jan 7, 1987 | K864925 | EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 Em Diagnostic Systems, Inc. | DIP |
| Jan 7, 1987 | K864554 | EASY-TEST PRIMIDONE ITEM NO. 67---/95 Em Diagnostic Systems, Inc. | DIP |
| Sep 29, 1986 | K863403 | PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS Technicon Instruments Corp. | DIP |
| Aug 25, 1986 | K855026 | ACCULEVEL PHENYTOIN TEST Syva / A Syntex Co. | DIP |
| Jul 7, 1986 | K862349 | EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 Em Diagnostic Systems, Inc. | DIP |
| Mar 5, 1986 | K860286 | IL TEST PHENYTOIN Allied Instrumentation Laboratory | DIP |
| Jan 22, 1986 | K860048 | DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN) Clinical Data, Inc. | DIP |
| Mar 20, 1985 | K850712 | EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY Syva Co. | DIP |
| Mar 19, 1985 | K842092 | SERALYZER ARIS PHENYTOIN REAGENT STRIPS Miles Laboratories, Inc. | DIP |
| Jan 23, 1985 | K844991 | EMIT PHENYTOIN ASSAY Syva Co. | DIP |
| Oct 11, 1984 | K843209 | PHENYTOIN ACA ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | DIP |
| Jul 9, 1984 | K842161 | VENTREZYME PHENYTOIN KIT IMMUNOASSAY Ventrex Laboratories, Inc. | DIP |
| Feb 3, 1984 | K834406 | EMIT QST PHENYTOIN ASSAY Syva Co. | DIP |
| Jan 30, 1984 | K833806 | CHEMKIT PHENYTOIN DIAG. KIT Abbott Laboratories | DIP |
| Sep 1, 1983 | K832419 | A-GENT PHERYTOIN Abbott Laboratories | DIP |
| Aug 1, 1983 | K832033 | EMIT AED PHENYTOIN ASSAY Syva Co. | DIP |
| Jul 10, 1981 | K811745 | VIRGO IPA FOR DETECTION OF PHENYTOIN Electro-Nucleonics Laboratories, Inc. | DIP |
| Mar 3, 1978 | K780218 | ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE Syva Co. | DIP |
| Dec 20, 1977 | K772179 | EMIT ANTIEPILEPTIC DRUG ASSAYS Syva Co. | DIP |
| Jul 15, 1977 | K771233 | PHENYTOIN ANALYTICAL TEST PACKS E.I. Dupont DE Nemours & Co., Inc. | DIP |
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