ACCESS PROLACTIN

Radioimmunoassay, Prolactin (lactogen)

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Prolactin.

Pre-market Notification Details

Device IDK941175
510k NumberK941175
Device Name:ACCESS PROLACTIN
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactDennis S Griffin
CorrespondentDennis S Griffin
BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-14
Decision Date1994-06-02

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