ACS PHENYTOIN ASSAY

Fluorescence Polarization Immunoassay, Diphenylhydantoin (total)

CIBA CORNING DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Phenytoin Assay.

Pre-market Notification Details

Device IDK955873
510k NumberK955873
Device Name:ACS PHENYTOIN ASSAY
ClassificationFluorescence Polarization Immunoassay, Diphenylhydantoin (total)
Applicant CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield,  MA  02052 -1688
ContactSteven R Rakitin
CorrespondentSteven R Rakitin
CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. Medfield,  MA  02052 -1688
Product CodeLGR  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-26
Decision Date1996-03-11

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