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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 K082227
FOIA Releasable 510(k) K082227
Device Name MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
Applicant
Sebia
400-1705 Corporate Dr.
Suite 400
Norcross,  GA  30093
Applicant Contact KAREN ANDERSON
Correspondent
Sebia
400-1705 Corporate Dr.
Suite 400
Norcross,  GA  30093
Correspondent Contact KAREN ANDERSON
Regulation Number864.7415
Classification Product Code
GKA  
Date Received08/07/2008
Decision Date 03/26/2009
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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