ARK Levetiracetam II Assay
FDA 510(k) K232522 · Ark Diagnostics, Inc.
510(k) numberK232522
Submission
- Device name
- ARK Levetiracetam II Assay
- Applicant
- Ark Diagnostics, Inc.
Fremont, CA, US - Received
- August 18, 2023
- Decision date
- February 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ORI – Levetiracetam Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
For the quantitative determination of levetiracetam in human serum or plasma.
Other 510(k)s with product code ORI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control…ORI · Traditional | Ark Diagnostics, Inc. | 11/02/2009SE |
More from Ark Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232017 | ARK Methotrexate II AssayLAO · Traditional | 12/20/2023SE |
| K231752 | ARK Hydrocodone AssayDJG · Traditional | 11/09/2023SE |
| K201089 | ARK Lacosamide AssayNWM · Traditional | 08/05/2021SE |
| K200197 | ARK Fentanyl II AssayDJG · Traditional | 02/26/2020SE |
| K182280 | ARK Tramadol AssayDJG · Traditional | 12/10/2018SE |
| K182779 | ARK EDDP AssayDJR · Traditional | 11/21/2018SE |
| K180427 | ARK Fentanyl AssayDJG · Traditional | 06/06/2018SE |
| K163359 | ARK Methotrexate AssayLAO · Special | 08/18/2017SE |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…POX · Traditional | 08/09/2016SE |
| K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…LAO · Traditional | 10/18/2011SE |
Questions and answers
When was ARK Levetiracetam II Assay cleared by the FDA?
ARK Levetiracetam II Assay (K232522) received a 510(k) decision of Substantially Equivalent on February 27, 2024, 193 days after the submission was received.
What is the product code of K232522?
The FDA product code is ORI – Levetiracetam Assay, a Class II (moderate risk) device regulated under 21 CFR 862.3350.