FETAL 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 Fetal Bovine Serum.

Pre-market Notification Details

Device IDK800781
510k NumberK800781
Device Name:FETAL BOVINE SERUM
ClassificationSera, Animal And Human
Applicant BIOLABS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKIS  
CFR Regulation Number864.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-08
Decision Date1980-04-21

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