510(k) Report

Devices descending from K091653

1 later device reach Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232522ARK Levetiracetam II AssayArk Diagnostics, Inc.20240—