510(k) Report

Devices descending from K030182

6 later devices reach Liquichek D-Dimer Control, Model 356, 357 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032017Liquichek D-Dimer Control Level 1, 2 and 3Bio-Rad20035—
+2K050799Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer ControlsBiosite Incorporated20054—
+3K100716Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd.20113—
+4K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC20162—
+5K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC20170—
+5K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC20170—