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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
510(k) Number K080003
Device Name BINAXNOW G6PD TEST
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 Number864.7360
Classification Product Code
JBF  
Date Received01/02/2008
Decision Date 10/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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