ARK Methotrexate II Assay— 510(k) K232017

Substantially Equivalent

Ark Diagnostics, Inc.

FDA 510(k) clearance K232017 for ARK Methotrexate II Assay, Substantially Equivalent on 2023-12-20. Applicant: Ark Diagnostics, Inc..

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code LAO
Advisory panel: Unknown
Date received: 2023-07-07
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.