510(k) Report

Devices descending from K971902

1 later device reach Roche Unimate HDL Direct Reagent, Roche Calibrator HDL Direct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973369Roche Unimate HDL Direct Reagen (with Pol Claim)Roche Diagnostic Systems, Inc.19970—