510(k) Report

Devices descending from K010814

1 later device reach Emit 2000 Carbamazepine Assay, Model OSR4F229 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…Ark Diagnostics, Inc.20160—