510(k) Report

Devices descending from K951635

6 later devices reach Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080—
+1K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc.19971—
+1K963974Image-Immunochemistry System Urine ImmunoglobulinBeckman Instruments, Inc.19972—
+2K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics200912
+2K994325Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc.20000—
+3K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH20230—