510(k) Report

Devices descending from K040379

1 later device reach Randox Immunoassay Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140522Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium…Randox Laboratories Limited201405