510(k) Report

Devices descending from K101754

3 later devices reach Thermo Scientific Cedia Opiate Oft Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203564SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation20211—
+1K133642Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls…Biophor Diagnostics, Inc.20140—
+2K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation20250—