510(k) Report

Devices descending from K003259

2 later devices reach Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242095Access Toxo IgM IIBeckman Coulter, Inc.20240—
+1K031506Access Immunoassay System Toxo Igm II AssayBeckman Coulter, Inc.20030—