510(k) Report

Devices descending from K050945

2 later devices reach Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063024Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral…Lin-Zhi International, Inc.20061—
+2K131653Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20140—