Thin Layer Chromatography, Ethosuximide
The Thin Layer Chromatography system for Ethosuximide is a laboratory analytical device used to detect and identify ethosuximide, an anticonvulsant drug, in patient specimens through thin-layer chromatographic separation. It is a Class 2 device requiring a 510(k) premarket notification. The product code is DNP, regulated under 21 CFR 862.3380, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DNP
- Device Class
- FDA class 2
- Regulation Number
- 862.3380
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K901531 | PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE | Jun 20, 1990 | Substantially Equivalent | Pioneering Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.