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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sera, Animal And Human
510(k) Number K870938
Device Name FETAL BOVINE SERUM
Applicant
Hyclone Laboratories, Inc.
1725 S. Hyclone Rd.
Logan,  UT  84321
Applicant Contact REX S SPENDLOVE,PHD
Correspondent
Hyclone Laboratories, Inc.
1725 S. Hyclone Rd.
Logan,  UT  84321
Correspondent Contact REX S SPENDLOVE,PHD
Regulation Number864.2800
Classification Product Code
KIS  
Date Received03/09/1987
Decision Date 03/31/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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