510(k) Report

Devices descending from K913133

5 later devices reach Chality Control Material (Assayed & Unassayed) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032453Roche Combitrol and Autotrol Plus B Multi Analyte ControlBionostics, Inc.20034—
+2K152553CueSee HypoxicEurotrol B.V.20160—
+2K131595Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVMEurotrol B.V.20130—
+2K121468Eurotrol Gas-Ise MetabolitesEurotrol B.V.20120—
+2K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics201204