510(k) Report

Devices descending from K993985

3 later devices reach Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062285Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc.20060—
+1K032365Benzodiazepine Enzyme ImmunoassayLin-Zhi International, Inc.20031—
+2K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc.20040—