Episcreen Oral Specimen Collection Device
by Epitope, Inc. 510(k)
Active
510(k) K973395
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973395 | Date13 Feb 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 11 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- PJD
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent