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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Erythropoietin
510(k) Number K183088
Device Name ADVIA Centaur Erythropoietin (EPO) assay
Applicant
Axis-Shield Diagnostics Limited
Luna Pl., The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
Axis-Shield Diagnostics Limited
Luna Pl., The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact Claire Dora
Regulation Number864.7250
Classification Product Code
GGT  
Date Received11/06/2018
Decision Date 08/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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