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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
Applicant
Infopia Co, Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact MARIA F GRIFFIN
Correspondent
Infopia Co, Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact MARIA F GRIFFIN
Regulation Number864.7470
Classification Product Code
LCP  
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
Predetermined Change
Control Plan Authorized		 No
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