Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARK Lacosamide Assay

K-Number: K201089 · 2021-08-05

ApplicantArk Diagnostics, Inc.
Decision Date2021-08-05
Product CodeNWM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ARK Lacosamide Assay is a medical device manufactured by Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-08-05 under approval number K201089. The device is classified under product code NWM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

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. It is manufactured by Ark Diagnostics, Inc.. The 510(k) number is K201089.

When was ARK Lacosamide Assay approved by the FDA?

ARK Lacosamide Assay received FDA 510(k) clearance on 2021-08-05, under approval number K201089.

What company makes ARK Lacosamide Assay?

ARK Lacosamide Assay is manufactured by Ark Diagnostics, Inc..

What is the FDA product code for ARK Lacosamide Assay?

The FDA product code for ARK Lacosamide Assay is NWM.

Other Devices by Ark Diagnostics, Inc.

K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control K163359ARK Methotrexate Assay DEN160033ARK Voriconazole II Assay Test System K182280ARK Tramadol Assay K182779ARK EDDP Assay K180427ARK Fentanyl Assay

View all 11 devices →

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.

↑