ACCESS(R) TOTAL T3

Radioimmunoassay, Total Triiodothyronine

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access(r) Total T3.

Pre-market Notification Details

Device IDK940833
510k NumberK940833
Device Name:ACCESS(R) TOTAL T3
ClassificationRadioimmunoassay, Total Triiodothyronine
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 CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-23
Decision Date1994-09-07

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