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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K884654
Device Name ALPHACALF SERUM
Applicant
Hyclone Laboratories, Inc.
1725 S. Hyclone Rd.
Logan,  UT  84321
Applicant Contact BRIM, PH.D.
Correspondent
Hyclone Laboratories, Inc.
1725 S. Hyclone Rd.
Logan,  UT  84321
Correspondent Contact BRIM, PH.D.
Regulation Number864.2220
Classification Product Code
KIT  
Date Received11/07/1988
Decision Date 11/30/1988
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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