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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 K012431
Device Name COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
Applicant
Bionostics, Inc.
2 Craig Rd.
Acton,  MA  01720
Applicant Contact KATHY STORRO
Correspondent
Bionostics, Inc.
2 Craig Rd.
Acton,  MA  01720
Correspondent Contact KATHY STORRO
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/31/2001
Decision Date 08/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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