510(k) Report

Devices descending from K011579

6 later devices reach Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082036Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories20081—
+1K071675Liquichek Tumor Marker ControlBio-Rad Laboratories20072—
+1K042815Quest Tumor Marker Control, Model 955Bio-Rad20040—
+2K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…Bio-Rad Laboratories20170—
+2K141073Liquichek Tumor Marker ControlBio-Rad Laboratories20140—
+2K101809Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc.20100—