ARK Levetiracetam II Assay
FDA 510(k) clearance K232522 · decided 2024-02-27
Clearance details
- K-number
- K232522
- Device name
- ARK Levetiracetam II Assay
- Applicant
- Ark Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-18
- Decision date
- 2024-02-27
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- ORI
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 (K091653) | Ark Diagnostics, Inc. | 2009-11-02 |
Recalls involving this device
No recalls on record reference this clearance.