510(k) Report

Devices descending from K000716

3 later devices reach Access CK-MB on the Access Immunoassay Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033155Biocentrex Cardiac PanelBiocentrex20040—
+1K030012CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372Beckman Coulter, Inc.20031—
+2K234005Access CK-MBBeckman Coulter, Inc.20240—