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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K891061
Device Name BIOTROL CALCIUM MONOREACTIF
Applicant
Biotrol, USA, Inc.
113 Branywine Pkwy.
Westchester,  PA  19380
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
113 Branywine Pkwy.
Westchester,  PA  19380
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1145
Classification Product Code
CJY  
Date Received03/01/1989
Decision Date 08/10/1989
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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