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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 K913133
Device Name CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
Applicant
Bionostics, Inc.
Two Craig Rd.
Acton,  MA  01720
Applicant Contact BRUCE R.WILLIAMS
Correspondent
Bionostics, Inc.
Two Craig Rd.
Acton,  MA  01720
Correspondent Contact BRUCE R.WILLIAMS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/16/1991
Decision Date 09/27/1991
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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