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FDA 510(k) Applications Submitted by MAINE STANDARDS COMPANY LLC
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
K133550
11/19/2013
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
MAINE STANDARDS COMPANY LLC
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