510(k) Report

Devices descending from K972929

5 later devices reach N Antiserum to Human Albumin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153560Optilite Low Level Albumin KitThe Binding Site Group, Ltd.20160—
+1K101203Tina-Quant Albumin Gen 2Roche Diagnostics201011
+1K042643Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I…Ortho-Clinical Diagnostics, Inc.200401
+1K033525Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114…Dade Behring, Inc.20040—
+2K113072Tina-Quant Albumin Gen.2Roche Diagnostics Operations20120—