Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033, Olympus D-Dimer Control
by Olympus Life & Material Science Europa GmbH (Irish 510(k)
Active
510(k) K070453
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070453 | Date11 Jun 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 10 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GHH
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7320
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent