ADULT BOVINE SERUM

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 Adult Bovine Serum.

Pre-market Notification Details

Device IDK870468
510k NumberK870468
Device Name:ADULT BOVINE SERUM
ClassificationSera, Animal And Human
Applicant HYCLONE LABORATORIES, INC. 1725 SOUTH HYCLONE RD. Logan,  UT  84321
ContactRex S Spendlove
CorrespondentRex S Spendlove
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 Received1987-02-03
Decision Date1987-03-24

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