INNOFLUOR PHENYTOIN

Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

INNOTRON DIAGNOSTICS

The following data is part of a premarket notification filed by Innotron Diagnostics with the FDA for Innofluor Phenytoin.

Pre-market Notification Details

Device IDK841706
510k NumberK841706
Device Name:INNOFLUOR PHENYTOIN
ClassificationFluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Applicant INNOTRON DIAGNOSTICS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLGR  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-23
Decision Date1984-05-22

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