Atlas FDA

LGR

15 FDA 510(k) clearances · Product code

58 daysmedian time to decision
126 days90th percentile
15clearances measured

FDA profile

Official device name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3350
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
ACS PHENYTOIN ASSAY (K955873)Ciba Corning Diagnostics Corp.1996-03-11
INNOFLUOR PHENYTOIN ASSAY SYSTEM (K955562)Oxis Intl., Inc.1996-01-24
AXSYM PHENYTOIN II (K953840)Abbott Laboratories1995-09-25
TDX(R)/TDXFLX(R) PHENYTOIN II (K946328)Abbott Laboratories1995-03-28
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (K943313)Sigma Diagnostics, Inc.1994-10-27
AXSYM PHENYTOIN ASSAY (K935375)Abbott Laboratories1994-06-21
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (K936131)Roche Diagnostic Systems, Inc.1994-03-11
OPUS PHENYTOIN TEST SYSTEM (K896868)Pb Diagnostic Systems, Inc.1990-01-02
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (K895827)Innotron of Oregon, Inc.1989-10-31
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (K872563)Innotron of Oregon, Inc.1987-08-21
IMMPULSE PHENYTOIN ASSAY REAGENT (K862554)Sclavo, Inc.1986-07-16
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR (K843824)Roche Diagnostic Systems, Inc.1985-02-01
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE (K844171)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-10
PHENYTOIN KIT FLUORESCENCE POLARIZATION (K842586)Windsor Laboratories, Inc.1984-09-26
INNOFLUOR PHENYTOIN (K841706)Innotron Diagnostics1984-05-22

Track LGR automatically

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