510(k) K870938

FETAL BOVINE SERUM by Hyclone Laboratories, Inc. — Product Code KIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1987
Date Received
March 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sera, Animal And Human
Device Class
Class I
Regulation Number
864.2800
Review Panel
PA
Submission Type