Immulon 1, 2, 3, and 4 Dividastrips Tm
by Dynatech Laboratories, Inc.
510(k) K894645
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894645 | Date17 Oct 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 11 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JTC
- Device Class
- Class I
- Regulation
- 21 CFR Part 866.2500
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent