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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 K121366
Device Name HEMOCUE HBA1C 501
Original Applicant
55 northern blvd.
suite 200
great neck,  NY  11021
Original Contact maria f griffin
Regulation Number864.7470
Classification Product Code
Date Received05/07/2012
Decision Date 09/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No