DAC-CEL HCG

Visual, Pregnancy Hcg, Prescription Use

BURROUGHS WELLCOME CO.

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

Pre-market Notification Details

Device IDK810215
510k NumberK810215
Device Name:DAC-CEL HCG
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant BURROUGHS WELLCOME CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-27
Decision Date1981-04-17

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