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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 K052291
Device Name CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
Applicant
Sebia
13805 Waterloo
Chelsea,  MI  48118
Applicant Contact KAREN ANDERSON
Correspondent
Sebia
13805 Waterloo
Chelsea,  MI  48118
Correspondent Contact KAREN ANDERSON
Regulation Number864.7415
Classification Product Code
GKA  
Date Received08/23/2005
Decision Date 06/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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