510(k) Report

Devices descending from K902935

2 later devices reach Roche Cobas Ready HDL Cholesterol Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023640Piccolo HDL Test SystemAbaxis, Inc.20031—
+2K120662Piccolo HDL-Capillary Test SystemAbaxis, Inc.20120—