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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 K122101
Device Name CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
Applicant
SEBIA
1705 CORPORATE DRIVE
SUITE 400
DULUTH,  GA  30093
Applicant Contact KAREN ANDERSON
Correspondent
SEBIA
1705 CORPORATE DRIVE
SUITE 400
DULUTH,  GA  30093
Correspondent Contact KAREN ANDERSON
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIS   JJX  
Date Received07/16/2012
Decision Date 12/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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