510(k) K232522
- Device
- ARK Levetiracetam II Assay
- Applicant
- Ark Diagnostics, Inc.
- 510(k) number
- K232522
- Product code
- ORI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-27
- Date received
- 2023-08-18
- Regulation
- 862.3350
- Classification name
- Levetiracetam Assay
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dionne Labatore
- Address
- 48089 Fremont Blvd. Fremont CA US 94538 94538
FDA Registration Numbers#
- 3005755244
Source Documents#
Other 510(k) Records For Product Code ORI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091653 | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 | Ark Diagnostics, Inc. | 2009-11-02 |