FDA 510(k) Applications Submitted by JAMES CHAMPLIN

FDA 510(k) Number Submission Date Device Name Applicant
K170864 03/23/2017 VALIDATE D-Dimer Calibration Verification / Linearity Test Kit Maine Standards Company LLC
K162705 09/28/2016 VALIDATE« D-Dimer Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY LLC
K152961 10/07/2015 VALIDATE D-Dimer Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY LLC
K142964 10/14/2014 VALIDATE Anemia Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY, LLC
K163498 12/13/2016 VALIDATE Heparin Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY, LLC
K123127 10/04/2012 VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 MAINE STANDARDS CO.
K133550 11/19/2013 VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT MAINE STANDARDS COMPANY LLC


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