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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K905280
Device Name BIOTROL BILIRUBIN C & T CONTROL
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 Number862.1660
Classification Product Code
JJX  
Date Received11/23/1990
Decision Date 02/04/1991
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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