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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 K870580
Device Name MLC NORMAL SERUM
Applicant
Rjo Biologicals, Inc.
6038 Troost Ave.
Kansas City,  MO  64110
Applicant Contact DAVID M CHARNECKI
Correspondent
Rjo Biologicals, Inc.
6038 Troost Ave.
Kansas City,  MO  64110
Correspondent Contact DAVID M CHARNECKI
Regulation Number864.2800
Classification Product Code
KIS  
Date Received02/11/1987
Decision Date 04/08/1987
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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