510(k) Report

Devices descending from K961824

1 later device reach Cobas Integra Reagent Cassettes for Albumin, Hbalc and Digoxin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990992Integra Reagent Cassette for Hemoglobin AlcRoche Diagnostics Corp.19990—