PHENYTOIN FPIA REAGENT SET AND CALIBRATORS

Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Phenytoin Fpia Reagent Set And Calibrators.

Pre-market Notification Details

Device IDK943313
510k NumberK943313
Device Name:PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
ClassificationFluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Applicant SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis,  MO  63103
ContactHoyle D Hill
CorrespondentHoyle D Hill
SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis,  MO  63103
Product CodeLGR  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-11
Decision Date1994-10-27

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