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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saccharogenic, Amylase
510(k) Number K872831
Device Name BIOTROL ALPHA AMYLASE
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 Number862.1070
Classification Product Code
CIJ  
Date Received07/17/1987
Decision Date 09/04/1987
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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