NEWBORN BOVINE SERUM

Sera, Animal And Human

BIOLABS, INC.

The following data is part of a premarket notification filed by Biolabs, Inc. with the FDA for Newborn Bovine Serum.

Pre-market Notification Details

Device IDK810903
510k NumberK810903
Device Name:NEWBORN BOVINE SERUM
ClassificationSera, Animal And Human
Applicant BIOLABS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKIS  
CFR Regulation Number864.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-03
Decision Date1981-04-14

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