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FDA 510(k) Applications Submitted by Amanda Brown
FDA 510(k) Number
Submission Date
Device Name
Applicant
K130122
01/17/2013
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
BECKMAN COULTER, INC
K190298
02/11/2019
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
Beckman Coulter Biomedical GmbH
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