510(k) Report

Devices descending from K061683

1 later device reach Tina-Quant Myoglobin Gen.2 Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories20130—