510(k) Report

Devices descending from K083799

5 later devices reach Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201089ARK Lacosamide AssayArk Diagnostics, Inc.20210—
+1K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…Ark Diagnostics, Inc.20160—
+1K101574Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control…Ark Diagnostics, Inc.20100—
+1K091653Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control…Ark Diagnostics, Inc.20091—
+2K232522ARK Levetiracetam II AssayArk Diagnostics, Inc.20240—