ARK Levetiracetam II Assay— 510(k) K232522
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K232522 for ARK Levetiracetam II Assay, Substantially Equivalent on 2024-02-27. Applicant: Ark Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ark Diagnostics, Inc.
- Product code
- Code ORI
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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