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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K874809
Device Name REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
Applicant
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1660
Classification Product Code
JJY  
Date Received11/20/1987
Decision Date 01/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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