510(k) Report

Devices descending from K090844

1 later device reach Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.20260—