ARK Methotrexate Assay— 510(k) K163359

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K163359 for ARK Methotrexate Assay, Substantially Equivalent on 2017-08-18. Applicant: Ark Diagnostics, Inc..

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code LAO
Advisory panel: Unknown
Date received: 2016-11-30
Decision date: 2017-08-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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