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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioassay, vitamin b12
510(k) Number K121946
Model FMABT100
Device Name AXIS-SHIELD ACVTIVE-B12
Original Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park, luna place
dundee, scotland,  UK dd2 1xa
Original Contact simon john richards
Regulation Number862.1810
Classification Product Code
CDD  
Date Received07/03/2012
Decision Date 03/22/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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