510(k) Report

Devices descending from K964842

2 later devices reach Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042494Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…Ortho-Clinical Diagnostics20040—
+1K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…Beckman Coulter, Inc.20030—