510(k) Report

Devices descending from K964695

1 later device reach Immage Immunochemistry System Albumin (Alb) Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142346Urine/CSF Albumin, Urine/CSF Albumin CalibratorBeckman Coulter Ireland, Inc.20140—