510(k) Report

Devices descending from K952337

3 later devices reach Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030553Arkit HBA1CArkray, Inc.20030—
+1K961824Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinRoche Diagnostic Systems, Inc.19961—
+2K990992Integra Reagent Cassette for Hemoglobin AlcRoche Diagnostics Corp.19990—