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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 K072686
Device Name AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
Applicant
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact Claire Dora
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJX  
Date Received09/24/2007
Decision Date 03/17/2008
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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