510(k) Report

Devices descending from K201938

1 later device reach LZI Fentanyl II Enzyme Immunoassay through their predicates, nearest generation first.

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