510(k) Report

Devices descending from K964716

7 later devices reach Sta Liatest Control [N]+[P] Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030182Liquichek D-Dimer Control, Model 356, 357Bio-Rad20036—
+2K032017Liquichek D-Dimer Control Level 1, 2 and 3Bio-Rad20035—
+3K050799Triage (R) D-Dimer Calibration Verification Controls; Triage (R) D-Dimer ControlsBiosite Incorporated20054—
+4K100716Audit Microcv D-Dimer Linearity Set, Model K717M-5Aalto Scientific, Ltd.20113—
+5K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC20162—
+6K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC20170—
+6K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC20170—