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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 K121842
Device Name ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
Applicant
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact CLAIRE I DORA
Correspondent
Axis-Shield Diagnostics, Ltd.
The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact CLAIRE I DORA
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JIT  
Date Received06/25/2012
Decision Date 12/12/2012
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
Recalls CDRH Recalls
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