Atlas FDA

DIP

44 FDA 510(k) clearances · Product code

48 daysmedian time to decision
213 days90th percentile
44clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Diphenylhydantoin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3350
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2018: 79 · 2019: 25 · 2020: 17 · 2021: 49 · 2022: 18 · 2023: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 (K080696)Abbott Laboratories2008-09-11
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS (K063145)Thermo Electron OY2007-10-17
ROCHE ONLINE TDM PHENYTOIN (K030428)Roche Diagnostics Corp.2003-04-28
RANDOX PHENYTOIN (K011393)Randox Laboratories, Ltd.2001-12-04
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (K011347)Syva Co.2001-05-17
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 (K000006)Diagnostic Products Corp.2000-02-28
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS (K993026)Syva Co.2000-01-27
ACE PHENYTOIN REAGENT, AED CALIBRATORS (K973414)Schiapparelli Biosystems, Inc.1997-11-04
CEDIA PHENYTOIN II ASSAY (K963840)Boehringer Mannheim Corp.1996-11-20
IL TEST PHENYTION CALIBRATORS (K943980)Instrumentation Laboratory CO1995-05-01
PHENYTION EIA TEST (K945725)Diagnostic Reagents, Inc.1995-02-03
ACE(TM) CEDIA(R) PHENYTOIN ASSAY (K944085)Schiapparelli Biosystems, Inc.1994-12-28
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN (K941142)Eastman Kodak Company1994-06-13
PARAMAX(R) PHENYTOIN REAGENT (K932686)Baxter Diagnostics, Inc.1993-11-26
BIOTRACK PHENYTOIN TEST CARTRIDGE (K915755)Biotrack, Inc.1992-07-23
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS (K913429)Syva Co.1991-08-26
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD (K911056)E.I. Dupont DE Nemours & Co., Inc.1991-04-03
CEDIA PHENYTOIN ASSAY (K905689)Microgenics Corp.1991-01-17
QMS TM- PHENYTOIN (K904815)Seradyn, Inc.1990-11-06
IL PHENYTOIN ASSAY SYSTEM (K902952)Instrumentation Laboratory CO1990-08-22
EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT (K901080)Immunotech Corp.1990-05-17
VISION PHENYTOIN (K896074)Abbott Laboratories1989-11-17
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY (K874856)Syva Co.1988-01-05
PHENYTOIN FPIA REAGENT SET (K870953)Sigma Diagnostics, Inc.1987-03-31
EASY-TEST PRIMIDONE ITEM NO. 67---/95 (K864554)Em Diagnostic Systems, Inc.1987-01-07
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 (K864925)Em Diagnostic Systems, Inc.1987-01-07
PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS (K863403)Technicon Instruments Corp.1986-09-29
ACCULEVEL PHENYTOIN TEST (K855026)Syva / A Syntex Co.1986-08-25
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 (K862349)Em Diagnostic Systems, Inc.1986-07-07
IL TEST PHENYTOIN (K860286)Allied Instrumentation Laboratory1986-03-05
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN) (K860048)Clinical Data, Inc.1986-01-22
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY (K850712)Syva Co.1985-03-20
SERALYZER ARIS PHENYTOIN REAGENT STRIPS (K842092)Miles Laboratories, Inc.1985-03-19
EMIT PHENYTOIN ASSAY (K844991)Syva Co.1985-01-23
PHENYTOIN ACA ANALYTICAL TEST PACK (K843209)E.I. Dupont DE Nemours & Co., Inc.1984-10-11
VENTREZYME PHENYTOIN KIT IMMUNOASSAY (K842161)Ventrex Laboratories, Inc.1984-07-09
EMIT QST PHENYTOIN ASSAY (K834406)Syva Co.1984-02-03
CHEMKIT PHENYTOIN DIAG. KIT (K833806)Abbott Laboratories1984-01-30
A-GENT PHERYTOIN (K832419)Abbott Laboratories1983-09-01
EMIT AED PHENYTOIN ASSAY (K832033)Syva Co.1983-08-01
VIRGO IPA FOR DETECTION OF PHENYTOIN (K811745)Electro-Nucleonics Laboratories, Inc.1981-07-10
ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE (K780218)Syva Co.1978-03-03
EMIT ANTIEPILEPTIC DRUG ASSAYS (K772179)Syva Co.1977-12-20
PHENYTOIN ANALYTICAL TEST PACKS (K771233)E.I. Dupont DE Nemours & Co., Inc.1977-07-15

Track DIP automatically

Every clearance here is in the API, with alerts when new ones post.