510(k) Report

Devices descending from K062242

3 later devices reach Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131652Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20142—
+2K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20210—
+2K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…Biophor Diagnostics, Inc.20150—