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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
Original Applicant
SEBIA
1705 corporate drive
suite 400
duluth,  GA  30093
Original 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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