← FDA Medical Device Classifications
Levetiracetam Assay
ORI · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3350
Classification
- FDA Product Code
ORI- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 862.3350
- Review panel
- TX
- Medical specialty
- Clinical Toxicology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
For the quantitative determination of levetiracetam in human serum or plasma.
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown