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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K091489
Device Name CLEARVIEW ADVANCED STREP A , MODEL 737-430
Applicant
Binax, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Applicant Contact ERIN E KENALEY
Correspondent
Binax, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Correspondent Contact ERIN E KENALEY
Regulation Number866.3740
Classification Product Code
GTY  
Date Received05/20/2009
Decision Date 09/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
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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