ACCESS CORTISOL REAGENTS

Radioimmunoassay, Cortisol

BIO-RAD LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK940221
510k NumberK940221
Device Name:ACCESS CORTISOL REAGENTS
ClassificationRadioimmunoassay, Cortisol
Applicant BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactJan Olsen
CorrespondentJan Olsen
BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
Product CodeCGR  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-18
Decision Date1994-04-26

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