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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 K860762
Device Name GAMMA-FREE HORSE SERUM
Applicant
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Applicant Contact BISHOP, PH.D.
Correspondent
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Correspondent Contact BISHOP, PH.D.
Regulation Number864.2800
Classification Product Code
KIS  
Date Received02/28/1986
Decision Date 03/10/1986
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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