510(k) Report

Devices descending from K100716

3 later devices reach Audit Microcv D-Dimer Linearity Set, Model K717M-5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC20162—
+2K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC20170—
+2K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC20170—