510(k) Report

Devices descending from K780913

13 later devices reach Additional Reagents Kits for Imm. System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994293Dimension C4 Flex Reagent CartridgeDade Behring, Inc.20000—
+1K994296Dimension C3 Flex Reagent CartridgeDade Behring, Inc.20000—
+1K994294Dimension TRNF Flex Reagent CartridgeDade Behring, Inc.20000—
+1K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc.19974—
+1K971958Synchron LX Systems Transferrin (TRFN) ReagentBeckman Instruments, Inc.19970—
+1K964842Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentBeckman Instruments, Inc.19972—
+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—
+2K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…Beckman Coulter, Inc.20030—
+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—
+4K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20130—