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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K910721
Device Name BIOTROL PROTEIN MULTILEVEL STANDARDS
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 Number862.1150
Classification Product Code
JIS  
Date Received02/20/1991
Decision Date 05/06/1991
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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