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FDA 510(k) Applications Submitted by Cherry Mun
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180427
02/16/2018
ARK Fentanyl Assay
ARK Diagnostics, Inc.
K182280
08/22/2018
ARK Tramadol Assay
ARK Diagnostics, Inc.
K182779
10/01/2018
ARK EDDP Assay
ARK Diagnostics, Inc.
K163359
11/30/2016
ARK Methotrexate Assay
ARK Diagnostics, Inc.
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