DKP — Radioimmunoassay, Phenobarbital Class II
FDA product code DKP covers "Radioimmunoassay, Phenobarbital", a Class II medical device regulated under 21 CFR 862.3660. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DKP
- 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 |
|---|---|---|---|
| K844167 | bd becton dickinson vacutainer systems preanalytic | ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT | November 27, 1984 |
| K800090 | bio-rad | FLUOROMATIC PHENOLBARBITAL FIA | January 23, 1980 |
| K772111 | clinical assays | IN VITRO PHENOBARBITAL RIA TEST | November 28, 1977 |