510(k) Report

Devices descending from K042725

2 later devices reach Quest Diagnostics Haircheck-DT (Opiates) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103161Omega Laboratories Hair Drug Screening Assay for OpiatesOmega Laboratories, Inc.20111—
+2K140671Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and HydrocodoneOmega Laboratories, Inc.20150—