510(k) Report

Devices descending from K082036

1 later device reach Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101809Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc.20100—