510(k) Report

Devices descending from K020395

3 later devices reach Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102210Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators…Lin-Zhi International, Inc.20102—
+2K113661Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi…Lin-Zhi International, Inc.20121—
+3K201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron Group20200—