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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 K140496
Device Name Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER BLVD.
MAIL STOP E1.SE.01
BREA,  CA  92821
Applicant Contact NANETTE CANEPA
Correspondent
BECKMAN COULTER, INC.
250 S. KRAEMER BLVD.
MAIL STOP E1.SE.01
BREA,  CA  92821
Correspondent Contact NANETTE CANEPA
Regulation Number862.1810
Classification Product Code
CDD  
Subsequent Product Codes
CGN   DBF   JJE   JLW  
Date Received02/27/2014
Decision Date 09/16/2014
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
Recalls CDRH Recalls
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