510(k) Report

Devices descending from K811927

2 later devices reach 1F Blocking Antibody (57 CO) Radioassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033603Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models…Beckman Coulter, Inc.20031—
+2K240800Access Intrinsic Factor AbBeckman Coulter, Inc.20240—