510(k) K201089
K201089 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK Lacosamide Assay". The FDA issued a decision of Substantially Equivalent on August 5, 2021. The device falls under product code NWM (Immunoassay, Anti-Seizure Drug), a Class II device regulated under 21 CFR 862.3350. Ark Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2021
- Date Received
- April 23, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay, Anti-Seizure Drug
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type
To aid in management of patients treated with anti-seizure drug.