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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 K172133
Device Name ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
Applicant
Axis-Shield Diagnostics, Ltd.
Luna Pl., The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
Axis-Shield Diagnostics, Ltd.
Luna Pl., The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact Claire Dora
Regulation Number862.1810
Classification Product Code
CDD  
Date Received07/14/2017
Decision Date 10/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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