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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 K162281
Device Name CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
Applicant
Sebia
1705 Corporate Dr., Suite 400
Norcross,  GA  30093
Applicant Contact KAREN ANDERSON
Correspondent
Sebia
1705 Corporate Dr., Suite 400
Norcross,  GA  30093
Correspondent Contact KAREN ANDERSON
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JJX  
Date Received08/15/2016
Decision Date 02/17/2017
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
Predetermined Change
Control Plan Authorized		 No
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