ARK Lacosamide Assay
K-Number: K201089 · 2021-08-05
Device Summary
Frequently Asked Questions
What is the ARK Lacosamide Assay?
ARK Lacosamide Assay is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K201089.
When did ARK Lacosamide Assay receive FDA 510(k) clearance?
ARK Lacosamide Assay received FDA 510(k) clearance on 2021-08-05, under 510(k) number K201089.
Who is the listed applicant for ARK Lacosamide Assay?
The FDA 510(k) record lists Ark Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ARK Lacosamide Assay?
The FDA product code for ARK Lacosamide Assay is NWM.
Other records listing Ark Diagnostics, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.