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FDA 510(k) Applications Submitted by Kenneth C. Kasper
FDA 510(k) Number
Submission Date
Device Name
Applicant
K111904
07/05/2011
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
ARK DIAGNOSTICS,INC
DEN160033
07/15/2016
ARK Voriconazole II Assay Test System
ARK DIAGNOSTICS, INC
K153596
12/16/2015
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
ARK DIAGNOSTICS, INC.
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