510(k) Report

Devices descending from K081008

2 later devices reach Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090844Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and ControlsLin-Zhi International, Inc.20091—
+2K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.20260—