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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Serological, Positive Control
510(k) Number K972986
Device Name ACCURUN 140 RUBELLA 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
MJX  
Date Received08/11/1997
Decision Date 10/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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