510(k) Report

Devices descending from K895883

9 later devices reach Beckman MA Microalbumin Reagent Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc.19971—
+1K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc.19975—
+1K965035Immage Immunochemistry System Microalbumin (MA) ReagentBeckman Instruments, Inc.19970—
+2K153560Optilite Low Level Albumin KitThe Binding Site Group, Ltd.20160—
+2K101203Tina-Quant Albumin Gen 2Roche Diagnostics201011
+2K042643Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I…Ortho-Clinical Diagnostics, Inc.200401
+2K033525Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114…Dade Behring, Inc.20040—
+2K994325Synchron CX Systems Microalbumin CalibratorBeckman Coulter, Inc.20000—
+3K113072Tina-Quant Albumin Gen.2Roche Diagnostics Operations20120—