GOAT ANTI-INFLUENZA ANTISERA

Antisera, Hai, Influenza Virus A, B, C

NORTHEAST BIOMEDICAL LABS., INC.

The following data is part of a premarket notification filed by Northeast Biomedical Labs., Inc. with the FDA for Goat Anti-influenza Antisera.

Pre-market Notification Details

Device IDK780004
510k NumberK780004
Device Name:GOAT ANTI-INFLUENZA ANTISERA
ClassificationAntisera, Hai, Influenza Virus A, B, C
Applicant NORTHEAST BIOMEDICAL LABS., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGNS  
CFR Regulation Number866.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-01-03
Decision Date1978-01-20

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