510(k) Report

Devices descending from K983387

1 later device reach Ontrak Testcup and Teststik Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990377Ontrak Testcup M2K and Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup…Roche Diagnostics Corp.19990—