INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET

Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

INNOTRON OF OREGON, INC.

The following data is part of a premarket notification filed by Innotron Of Oregon, Inc. with the FDA for Innofluor Phenytoin Manual Fpia Reagent Set.

Pre-market Notification Details

Device IDK895827
510k NumberK895827
Device Name:INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
ClassificationFluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Applicant INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland,  OR  97202
ContactCraig Smart
CorrespondentCraig Smart
INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland,  OR  97202
Product CodeLGR  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-02
Decision Date1989-10-31

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