DAC-CEL TSH

Radioimmunoassay, Thyroid-stimulating Hormone

BURROUGHS WELLCOME CO.

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

Pre-market Notification Details

Device IDK810213
510k NumberK810213
Device Name:DAC-CEL TSH
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant BURROUGHS WELLCOME CO. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-27
Decision Date1981-02-10

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