LFN — Nephelometric Inhibition Immunoassay, Phenobarbital Class II
FDA product code LFN covers "Nephelometric Inhibition Immunoassay, Phenobarbital", a Class II medical device regulated under 21 CFR 862.3660. Submissions are reviewed by the Clinical Toxicology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LFN
- Device Class
- Class II
- Regulation Number
- 862.3660
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K934388 | seradyn | QMS PHENOBARBITAL | February 25, 1994 |
| K864612 | coulter electronics | DART PHENOBARBITAL ASSAY SYSTEM | January 13, 1987 |
| K860304 | e.i. dupont de nemours and co | DUPONT PHENOBARBITAL ASSAY | February 28, 1986 |
| K860303 | e.i. dupont de nemours and co | DUPONT PHENOBARBITAL CALIBRATOR | February 28, 1986 |
| K821543 | electro-nucleonics laboratories | IPA FOR DETECTION OF PHENOBARBITAL | June 3, 1982 |