510(k) Report

Devices descending from K771603

19 later devices reach Immochemistry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…Beckman Coulter, Inc.20030—
+1K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc.19974—
+1K964842Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentBeckman Instruments, Inc.19972—
+1K964766Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)Beckman Instruments, Inc.19974—
+1K965108Synchron LX Systems Immunoglobulin G/a/M ReagentBeckman Instruments, Inc.199702
+1K963868Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)Beckman Instruments, Inc.199772
+1K962294Immage Immunochemistry SystemBeckman Instruments, Inc.199602
+2K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20053—
+2K042494Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…Ortho-Clinical Diagnostics20040—
+2K993547Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc)…Beckman Coulter, Inc.200021
+2K993549Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…Beckman Coulter, Inc.20003—
+3K183151Optilite IgA CSF KitThe Binding Site Group, Ltd.20190—
+3K130122Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman…Beckman Coulter, Inc.20140—
+3K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc.200611
+3K060940Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…Ortho-Clinical Diagnostics, Inc.20060—
+3K060130Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc.20060—
+3K032014N Latex IgmDade Behring, Inc.200301
+3K024038N Latex IgaDade Behring, Inc.20030—
+4K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20130—