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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 K050574
FOIA Releasable 510(k) K050574
Device Name AFINION HBALC
Applicant
Axis-Shield Poc AS
P.O. Box 262069
San Diego,  CA  92196
Applicant Contact RONALD G LEONARDI
Correspondent
Axis-Shield Poc AS
P.O. Box 262069
San Diego,  CA  92196
Correspondent Contact RONALD G LEONARDI
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JJX   JQT  
Date Received03/07/2005
Decision Date 07/22/2005
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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