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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 K872785
Device Name BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
Applicant
Biotrol, USA, Inc.
P.O. Box 562
Berwyn,  PA  19312
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
P.O. Box 562
Berwyn,  PA  19312
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/14/1987
Decision Date 08/26/1987
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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