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FDA 510(k) Applications Submitted by Geraldine Fuentespina
FDA 510(k) Number
Submission Date
Device Name
Applicant
K161837
07/05/2016
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
BECKMAN COULTER INC.
K162208
08/05/2016
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
BECKMAN COULTER INC.
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