510(k) Report

Devices descending from K940433

9 later devices reach Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983807Lyphochek Tumor Marker Control, Model #580Bio-Rad19988—
+2K992172Lyphochek Tumor Marker Control, Model 580Bio-Rad19997—
+3K011579Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580Bio-Rad20016—
+4K082036Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakBio-Rad Laboratories20081—
+4K071675Liquichek Tumor Marker ControlBio-Rad Laboratories20072—
+4K042815Quest Tumor Marker Control, Model 955Bio-Rad20040—
+5K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…Bio-Rad Laboratories20170—
+5K141073Liquichek Tumor Marker ControlBio-Rad Laboratories20140—
+5K101809Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc.20100—