510(k) Report

Devices descending from K030012

1 later device reach CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234005Access CK-MBBeckman Coulter, Inc.20240—