510(k) Report

Devices descending from K150502

2 later devices reach DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231752ARK Hydrocodone AssayArk Diagnostics, Inc.20230—
+1K173195DRI Hydrocodone AssayMicrogenics Corporation20180—