Product Code: DLP
FDA class 2
21 CFR 862.3350
Radioimmunoassay, Diphenylhydantoin
Clinical Toxicology
The Radioimmunoassay for Diphenylhydantoin (phenytoin) is a laboratory test system using radioisotopic labeling to quantify this anticonvulsant drug in patient serum or plasma for therapeutic drug monitoring. It is a Class 2 device requiring 510(k) premarket notification before it can be marketed. The product code is DLP, regulated under 21 CFR 862.3350, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
12
Research product code DLP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- DLP
- Device Class
- FDA class 2
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K894527 | FPR PHENYTOIN KIT | Sep 25, 1989 | Substantially Equivalent | Colony Laboratories, Inc. |
| K811775 | KALLESTAD ANTISERA TO PHENYTOIN | Jul 10, 1981 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K792640 | FLUOROMATIC PHENYTOIN FIA | Jan 11, 1980 | Substantially Equivalent | Bio-Rad |
| K791896 | CENTRIA PHENYTOIN RIA TEST SET | Oct 17, 1979 | Substantially Equivalent | Ventrex Laboratories, Inc. |
| K770779 | PHENYTOIN RIA KIT | Jun 17, 1977 | Substantially Equivalent | Amersham Corp. |