510(k) Report

Devices descending from K952309

4 later devices reach N Latex Iga through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993549Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…Beckman Coulter, Inc.20003—
+2K183151Optilite IgA CSF KitThe Binding Site Group, Ltd.20190—
+2K060130Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc.20060—
+2K024038N Latex IgaDade Behring, Inc.20030—