FDA 510(k) Applications Submitted by Shawn Kaplan

FDA 510(k) Number Submission Date Device Name Applicant
K121232 04/24/2012 K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR KAMIYA BIOMEDICAL COMPANY
K091486 05/19/2009 K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR KAMIYA BIOMEDICAL CO.
K192727 09/27/2019 K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) Kamiya Biomedical Company
K093137 10/05/2009 K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL KAMIYA BIOMEDICAL CO.


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