510(k) Report

Devices descending from K122703

2 later devices reach Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20191—
+2K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20210—