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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 K190298
Device Name DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
Applicant
Beckman Coulter Biomedical GmbH
Sauerbruchstr. 50
Munich,  DE 81377
Applicant Contact Amanda Brown
Correspondent
Beckman Coulter Biomedical GmbH
Sauerbruchstr. 50
Munich,  DE 81377
Correspondent Contact Amanda Brown
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
CGN   JJE   JLW   JMG  
Date Received02/11/2019
Decision Date 10/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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