510(k) Report

Devices descending from K940353

7 later devices reach Beckman Beta-2-Microglobulin (B2M) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983895Immage Immunochemistry System Beta-2 Microglobulin ReagentBeckman Coulter, Inc.19980—
+1K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc.19974—
+1K973813Immunochemistry System Beta-2-Microglobulin ReagentBeckman Instruments, Inc.19970—
+2K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20053—
+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—