Propoxphene Eia Test
by Diagnostic Reagents, Inc. 510(k)
Active
510(k) K943414
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943414 | Date9 Sep 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3700
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent