GOAT SERUM (29-391-54)

Sera, Animal And Human

FLOW LABORATORIES, INC.

The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Goat Serum (29-391-54).

Pre-market Notification Details

Device IDK860752
510k NumberK860752
Device Name:GOAT SERUM (29-391-54)
ClassificationSera, Animal And Human
Applicant FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean,  VA  22102
ContactBishop, Ph.d.
CorrespondentBishop, Ph.d.
FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean,  VA  22102
Product CodeKIS  
CFR Regulation Number864.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-28
Decision Date1986-03-10

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