BOVINE CALF SERUM SUPPLEMENTED #A-2159

Sera, Animal And Human

HYCLONE LABORATORIES, INC.

The following data is part of a premarket notification filed by Hyclone Laboratories, Inc. with the FDA for Bovine Calf Serum Supplemented #a-2159.

Pre-market Notification Details

Device IDK880471
510k NumberK880471
Device Name:BOVINE CALF SERUM SUPPLEMENTED #A-2159
ClassificationSera, Animal And Human
Applicant HYCLONE LABORATORIES, INC. 1725 SOUTH HYCLONE RD. Logan,  UT  84321
ContactRex S Spendlove,phd
CorrespondentRex S Spendlove,phd
HYCLONE LABORATORIES, INC. 1725 SOUTH HYCLONE RD. Logan,  UT  84321
Product CodeKIS  
CFR Regulation Number864.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-03
Decision Date1988-04-04

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