510(k) Report

Devices descending from K970509

6 later devices reach Innoflour Calibrator Reagent Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083799Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models…Ark Diagnostics, Inc.20095—
+2K201089ARK Lacosamide AssayArk Diagnostics, Inc.20210—
+2K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…Ark Diagnostics, Inc.20160—
+2K101574Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control…Ark Diagnostics, Inc.20100—
+2K091653Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control…Ark Diagnostics, Inc.20091—
+3K232522ARK Levetiracetam II AssayArk Diagnostics, Inc.20240—