510(k) Report

Devices descending from K993549

3 later devices reach Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183151Optilite IgA CSF KitThe Binding Site Group, Ltd.20190—
+1K060130Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc.20060—
+1K024038N Latex IgaDade Behring, Inc.20030—