Thin Layer Chromatography, Propoxyphene
The Thin Layer Chromatography system for Propoxyphene is a laboratory analytical device used to detect and identify propoxyphene, an opioid analgesic, in patient specimens through thin-layer chromatographic separation for toxicological screening. It is a Class 2 device requiring a 510(k) premarket notification. The product code is DPN, regulated under 21 CFR 862.3700, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
Research product code DPN 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
- DPN
- Device Class
- FDA class 2
- Regulation Number
- 862.3700
- 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 |
|---|---|---|---|---|
| K040802 | HEMOSONIC 200HEMODYNAMIC MONITOR | Apr 28, 2004 | Substantially Equivalent | Arrow Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.