510(k) Report

Devices descending from K011275

4 later devices reach Psychemedics Ria Phencyclidine Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111928Psychemedics Phencyclidine EiaPsychemedics Corp.20121—
+1K101059Omega Laboratories Hair Drug Screening Assay for PhencyclidineOmega Laboratories, Inc.20101—
+2K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation20220—
+2K131181Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc.20130—