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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
Original Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park
dundee, scotland,  GB dd2 1xa
Original 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
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