510(k) Report

Devices descending from K933078

3 later devices reach Beckman Alpha-1-Microglobulin (A1M) Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc.19971—
+1K965033Immage Immunochemistry System Alpha-1-Microglobulin (AI) ReagentBeckman Instruments, Inc.19970—
+2K994325Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc.20000—