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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 K931141
Device Name BIOTROL AMYLASE CNPG3
Applicant
Biotrol, USA, Inc.
115 Summit Dr.
Exton,  PA  19341
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
115 Summit Dr.
Exton,  PA  19341
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1070
Classification Product Code
CIJ  
Date Received03/05/1993
Decision Date 05/26/1993
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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