FDA 510(k) Applications Submitted by ERI HIRUMI

FDA 510(k) Number Submission Date Device Name Applicant
K053090 11/02/2005 DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR BECKMAN COULTER, INC.
K053612 12/27/2005 DRI-STAT ACID PHOSPHATASE REAGENT BECKMAN COULTER, INC.


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