LFO — Nephelometric Inhibition Immunoassay, Diphenylhydantoin Class II
FDA product code LFO covers "Nephelometric Inhibition Immunoassay, Diphenylhydantoin", a Class II medical device regulated under 21 CFR 862.3350. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- LFO
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K880294 | coulter electronics | DART PHENYTOIN | May 27, 1988 |