510(k) Report

Devices descending from K972513

4 later devices reach Tinaquant Myoglobin Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061683Tina-Quant Myoglobin Gen.2 Test SystemRoche Diagnostics Corp.200611
+1K983176Elecsys Myoglobin Stat AssayBoehringer Mannheim Corp.19981—
+2K123785Diazyme Myoglobin; Assay, Calibrator Set, Control SetDiazyme Laboratories20130—
+2K083260Elecsys Myoglobin Stat, and Elecsys MyoglobinRoche Diagnostics20090—