510(k) Report

Devices descending from K032017

5 later devices reach Liquichek D-Dimer Control Level 1, 2 and 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050799Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer ControlsBiosite Incorporated20054—
+2K100716Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd.20113—
+3K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC20162—
+4K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC20170—
+4K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC20170—