510(k) Report

Devices descending from K181159

2 later devices reach LZI Fentanyl Enzyme Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201938LZI Fentanyl II Enzyme ImmunoassayLin-Zhi International, Inc.20201—
+2K251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.20250—