510(k) Report

Devices descending from K050799

4 later devices reach Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100716Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd.20113—
+2K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC20162—
+3K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC20170—
+3K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC20170—