510(k) Report

Devices descending from K993983

1 later device reach Syva Emit II Plus Phencyclidine Assay, Model 9J029UL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062094Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat…Ortho-Clinical Diagnostics, Inc.20060—