ACCESS PROGESTERONE ASSAY

Radioimmunoassay, Progesterone

BIO-RAD LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK955769
510k NumberK955769
Device Name:ACCESS PROGESTERONE ASSAY
ClassificationRadioimmunoassay, Progesterone
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 CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-21
Decision Date1996-02-05

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