Radioimmunoassay, Phenobarbital
The Radioimmunoassay for Phenobarbital is a quantitative laboratory test employing radiolabeled phenobarbital and antibody-based methodology to measure phenobarbital levels in patient blood, supporting therapeutic drug monitoring in patients being treated for epilepsy or other seizure disorders. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3660 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DKP
- Device Class
- FDA class 2
- Regulation Number
- 862.3660
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K844167 | ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT | Nov 27, 1984 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K800090 | FLUOROMATIC PHENOLBARBITAL FIA | Jan 23, 1980 | Substantially Equivalent | Bio-Rad |
| K772111 | IN VITRO PHENOBARBITAL RIA TEST | Nov 28, 1977 | Substantially Equivalent | Clinical Assays, Inc. |