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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K032453
Device Name ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
Applicant
Bionostics, Inc.
7 Jackson Rd.
Devens,  MA  01432
Applicant Contact KATHLEEN STORRO
Correspondent
Bionostics, Inc.
7 Jackson Rd.
Devens,  MA  01432
Correspondent Contact KATHLEEN STORRO
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/11/2003
Decision Date 08/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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