510(k) Report

Devices descending from K935320

3 later devices reach Phencyclidine Eia Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation20150—
+1K020254Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011Lin-Zhi International, Inc.20021—
+2K033866Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)Lin-Zhi International, Inc.20040—