510(k) Report

Devices descending from K993208

7 later devices reach STC Methamphetamine Intercept Micro-Plate Eia, Model 1104I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101753Thermo Scientific Cedia Methamphetamine Oft AssayMicrogenics Corp.20111—
+1K093884Roche Fludi MethamphetamineRoche Diagnostics20110—
+1K062242Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators and ControlsLin-Zhi International, Inc.20063—
+2K133047Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…Biophor Diagnostics, Inc.20140—
+2K131652Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc.20142—
+3K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20210—
+3K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…Biophor Diagnostics, Inc.20150—