Enzyme Immunoassay, Diphenylhydantoin

FDA product code DIP · 44 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3350
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-07-15 – 2008-09-11

DIP 2008-09-11

ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01

Applicant Abbott Laboratories

K number K080696

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DIP 2007-10-17

PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

Applicant Thermo Electron OY

K number K063145

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DIP 2003-04-28

ROCHE ONLINE TDM PHENYTOIN

Applicant Roche Diagnostics Corp.

K number K030428

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DIP 2001-12-04

RANDOX PHENYTOIN

Applicant Randox Laboratories, Ltd.

K number K011393

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DIP 2001-05-17

EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

Applicant Syva Co.

K number K011347

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DIP 2000-02-28

IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6

Applicant Diagnostic Products Corp.

K number K000006

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DIP 2000-01-27

ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS

Applicant Syva Co.

K number K993026

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DIP 1997-11-04

ACE PHENYTOIN REAGENT, AED CALIBRATORS

Applicant Schiapparelli Biosystems, Inc.

K number K973414

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DIP 1996-11-20

CEDIA PHENYTOIN II ASSAY

Applicant Boehringer Mannheim Corp.

K number K963840

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DIP 1995-05-01

IL TEST PHENYTION CALIBRATORS

Applicant Instrumentation Laboratory CO

K number K943980

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DIP 1995-02-03

PHENYTION EIA TEST

Applicant Diagnostic Reagents, Inc.

K number K945725

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DIP 1994-12-28

ACE(TM) CEDIA(R) PHENYTOIN ASSAY

Applicant Schiapparelli Biosystems, Inc.

K number K944085

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DIP 1994-06-13

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN

Applicant Eastman Kodak Company

K number K941142

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DIP 1993-11-26

PARAMAX(R) PHENYTOIN REAGENT

Applicant Baxter Diagnostics, Inc.

K number K932686

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DIP 1992-07-23

BIOTRACK PHENYTOIN TEST CARTRIDGE

Applicant Biotrack, Inc.

K number K915755

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DIP 1991-08-26

EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS

Applicant Syva Co.

K number K913429

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DIP 1991-04-03

DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K911056

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DIP 1991-01-17

CEDIA PHENYTOIN ASSAY

Applicant Microgenics Corp.

K number K905689

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DIP 1990-11-06

QMS TM- PHENYTOIN

Applicant Seradyn, Inc.

K number K904815

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DIP 1990-08-22

IL PHENYTOIN ASSAY SYSTEM

Applicant Instrumentation Laboratory CO

K number K902952

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DIP 1990-05-17

EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT

Applicant Immunotech Corp.

K number K901080

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DIP 1989-11-17

VISION PHENYTOIN

Applicant Abbott Laboratories

K number K896074

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DIP 1988-01-05

EMIT CONVENIENCE PACK: PHENYTOIN ASSAY

Applicant Syva Co.

K number K874856

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DIP 1987-03-31

PHENYTOIN FPIA REAGENT SET

Applicant Sigma Diagnostics, Inc.

K number K870953

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DIP 1987-01-07

EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95

Applicant Em Diagnostic Systems, Inc.

K number K864925

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DIP 1987-01-07

EASY-TEST PRIMIDONE ITEM NO. 67---/95

Applicant Em Diagnostic Systems, Inc.

K number K864554

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DIP 1986-09-29

PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS

Applicant Technicon Instruments Corp.

K number K863403

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DIP 1986-08-25

ACCULEVEL PHENYTOIN TEST

Applicant Syva / A Syntex Co.

K number K855026

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DIP 1986-07-07

EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93

Applicant Em Diagnostic Systems, Inc.

K number K862349

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DIP 1986-03-05

IL TEST PHENYTOIN

Applicant Allied Instrumentation Laboratory

K number K860286

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DIP 1986-01-22

DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)

Applicant Clinical Data, Inc.

K number K860048

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DIP 1985-03-20

EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY

Applicant Syva Co.

K number K850712

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DIP 1985-03-19

SERALYZER ARIS PHENYTOIN REAGENT STRIPS

Applicant Miles Laboratories, Inc.

K number K842092

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DIP 1985-01-23

EMIT PHENYTOIN ASSAY

Applicant Syva Co.

K number K844991

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DIP 1984-10-11

PHENYTOIN ACA ANALYTICAL TEST PACK

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K843209

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DIP 1984-07-09

VENTREZYME PHENYTOIN KIT IMMUNOASSAY

Applicant Ventrex Laboratories, Inc.

K number K842161

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DIP 1984-02-03

EMIT QST PHENYTOIN ASSAY

Applicant Syva Co.

K number K834406

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DIP 1984-01-30

CHEMKIT PHENYTOIN DIAG. KIT

Applicant Abbott Laboratories

K number K833806

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DIP 1983-09-01

A-GENT PHERYTOIN

Applicant Abbott Laboratories

K number K832419

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DIP 1983-08-01

EMIT AED PHENYTOIN ASSAY

Applicant Syva Co.

K number K832033

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DIP 1981-07-10

VIRGO IPA FOR DETECTION OF PHENYTOIN

Applicant Electro-Nucleonics Laboratories, Inc.

K number K811745

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DIP 1978-03-03

ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE

Applicant Syva Co.

K number K780218

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DIP 1977-12-20

EMIT ANTIEPILEPTIC DRUG ASSAYS

Applicant Syva Co.

K number K772179

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DIP 1977-07-15

PHENYTOIN ANALYTICAL TEST PACKS

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K771233

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