510(k) Report

Devices descending from K963868

7 later devices reach Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993547Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc)…Beckman Coulter, Inc.200021
+1K993549Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…Beckman Coulter, Inc.20003—
+2K183151Optilite IgA CSF KitThe Binding Site Group, Ltd.20190—
+2K130122Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman…Beckman Coulter, Inc.20140—
+2K060130Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc.20060—
+2K032014N Latex IgmDade Behring, Inc.200301
+2K024038N Latex IgaDade Behring, Inc.20030—