510(k) Report

Devices descending from K960669

7 later devices reach Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd.202501
+1K203184HYDRASHIFT 2/4 isatuximabSebia20210—
+1K172195HYDRASHIFT 2/4 daratumumab, daratumumab ControlSebia20181—
+1K130500Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex…Sebia20132—
+2K192095CAPI 3 Immunotyping, Capillarys 3 TeraSebia20190—
+2K190851HYDRASHIFT 2/4 daratumumabSebia20190—
+2K161928Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia20161—