510(k) Report

Devices descending from K022707

11 later devices reach Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093577Liquichek Opiate ControlBio-Rad Laboratories20100—
+1K062165Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics200705
+1K063164Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat…Ortho-Clinical Diagnostics, Inc.200601
+1K062285Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc.20060—
+1K062460Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat Performance Verifiers I…Ortho-Clinical Diagnostics, Inc.200601
+1K062077Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics, Inc.200615
+1K062637Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I…Ortho-Clinical Diagnostics, Inc.20060—
+1K062094Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat…Ortho-Clinical Diagnostics, Inc.20060—
+1K062123Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc.200601
+1K042865Liquichek Urine Toxicology Control, (Levels S1S and S2S)Bio-Rad20040—
+2K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…Immunalysis Corporation20150—