INNOTRON INNOFLUOR PHEYTOIN 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 Innotron Innofluor Pheytoin Reagent Set.

Pre-market Notification Details

Device IDK872563
510k NumberK872563
Device Name:INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
ClassificationFluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Applicant INNOTRON OF OREGON, INC. 4432 SE 16TH AVE. Portland,  OR  97202
ContactBuck, Ph.d
CorrespondentBuck, Ph.d
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 Received1987-06-24
Decision Date1987-08-21

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