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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Hemoglobin Quantitation
510(k) Number K112491
Device Name SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
Applicant
Sebia
Parc Technologique Leonard De Vinci
Evry,  FR 91008
Applicant Contact KAREN ANDERSON
Correspondent
Sebia
Parc Technologique Leonard De Vinci
Evry,  FR 91008
Correspondent Contact KAREN ANDERSON
Regulation Number864.7415
Classification Product Code
GKA  
Date Received08/29/2011
Decision Date 05/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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