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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 K971406
Device Name ACCURUN 120 HAV IGG POSITIVE CONTROL
Applicant
Boston Biomedica, Inc.
375 W. St.
West Bridgewater,  MA  02379
Applicant Contact PATRICIA E GARRETT
Correspondent
Boston Biomedica, Inc.
375 W. St.
West Bridgewater,  MA  02379
Correspondent Contact PATRICIA E GARRETT
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/16/1997
Decision Date 08/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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