510(k) Report

Devices descending from K141055

3 later devices reach Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsMicrogenics Corporation20152—
+2K231752ARK Hydrocodone AssayArk Diagnostics, Inc.20230—
+2K173195DRI Hydrocodone AssayMicrogenics Corporation20180—