510(k) Report

Devices descending from K082085

3 later devices reach Capillarys Immunotyping, Model 2100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130500Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex…Sebia20132—
+2K192095CAPI 3 Immunotyping, Capillarys 3 TeraSebia20190—
+2K161928Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia20161—