510(k) Report

Devices descending from K101746

3 later devices reach Thermo Scientific Cedia Phencyclidine (PCP) Oft Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122703Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…Biophor Diagnostics, Inc.20132—
+2K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20191—
+3K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20210—