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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Direct Antigen, Positive Control
510(k) Number K083744
Device Name BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
Applicant
Binax, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Applicant Contact Anne Jepson
Correspondent
Binax, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Correspondent Contact Anne Jepson
Regulation Number862.1660
Classification Product Code
MJZ  
Date Received12/16/2008
Decision Date 09/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
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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