Product Code: DKH
FDA class 2
21 CFR 862.3350
Gas Chromatography, Diphenylhydantoin
Clinical Toxicology
The Gas Chromatography Diphenylhydantoin test is a laboratory assay employing gas chromatographic separation to detect and quantify diphenylhydantoin (phenytoin), an anticonvulsant drug, in patient specimens for therapeutic drug monitoring in epilepsy management. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3350 within the Clinical Toxicology specialty. The device qualifies for third-party 510(k) review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
2
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Basic Information
- Product Code
- DKH
- 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
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.