CIBA CORNING ACS ESTRADIOL IMMUNOASSAY

Radioimmunoassay, Estradiol

CIBA CORNING DIAGNOSTICS CORP.

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

Pre-market Notification Details

Device IDK932715
510k NumberK932715
Device Name:CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
ClassificationRadioimmunoassay, Estradiol
Applicant CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole,  MA  02032
ContactWilliam J Pignato
CorrespondentWilliam J Pignato
CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole,  MA  02032
Product CodeCHP  
CFR Regulation Number862.1260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-04
Decision Date1993-12-03

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