510(k) Report

Devices descending from K031231

9 later devices reach Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070848Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435XBio-Rad, Diagnostics Grp.20076—
+1K050328Pregnancy-SkreenBiochemical Diagnostic, Inc.200502
+1K042446Quantify Control and Quantify Plus ControlsBio-Rad Laboratories, Inc.20041—
+2K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc.20143—
+2K103387Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip…ACON Laboratories, Inc.20111—
+3K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd.20240—
+3K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd.20191—
+3K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…ACON Laboratories, Inc.20150—
+4K252619Qscheck UisacrQstag, Inc.20260—