ELISA TUBE PROLACTIN TEST KIT

Radioimmunoassay, Prolactin (lactogen)

BIO CLINIC CO.

The following data is part of a premarket notification filed by Bio Clinic Co. with the FDA for Elisa Tube Prolactin Test Kit.

Pre-market Notification Details

Device IDK920921
510k NumberK920921
Device Name:ELISA TUBE PROLACTIN TEST KIT
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant BIO CLINIC CO. 5977 SOUTHWEST AVE. St. Louis,  MI  63139
ContactBruce F Watkins
CorrespondentBruce F Watkins
BIO CLINIC CO. 5977 SOUTHWEST AVE. St. Louis,  MI  63139
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-28
Decision Date1992-04-08

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