DAC-CEL T3

Radioimmunoassay, Total Triiodothyronine

BURROUGHS WELLCOME CO.

The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Dac-cel T3.

Pre-market Notification Details

Device IDK791232
510k NumberK791232
Device Name:DAC-CEL T3
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant BURROUGHS WELLCOME CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-02
Decision Date1979-09-04

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