510(k) Report

Devices descending from K000534

3 later devices reach Cobas Integra Reagent Cassette for Rheumatoid Factor II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041863Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16…Ortho-Clinical Diagnostics, Inc.200421
+2K052645Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS…Ortho-Clinical Diagnostics20051—
+3K060650Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc.20060—