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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K912748
Device Name BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
Applicant
Binax, Inc.
95 Darling Ave.
S. Portland,  ME  04106
Applicant Contact JAMES C JACOBSEN
Correspondent
Binax, Inc.
95 Darling Ave.
S. Portland,  ME  04106
Correspondent Contact JAMES C JACOBSEN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received06/21/1991
Decision Date 10/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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