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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 K161364
Device Name BinaxNOW G6PD Test
Applicant
Alere Scarborough, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Applicant Contact Angela Drysdale
Correspondent
Alere Scarborough, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Correspondent Contact Angela Drysdale
Regulation Number864.7360
Classification Product Code
JBF  
Date Received05/17/2016
Decision Date 06/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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