510(k) Report

Devices descending from K011300

1 later device reach Emit II Plus Cannabinoid Assay, Model OSR9N229 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063164Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat…Ortho-Clinical Diagnostics, Inc.200601