Fresenius Com.tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L, C5L-T Platelet Sets (5-Day Storage)
by Fresenius Medical Care North America
510(k) K060734
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 | NumberK060734 | Date5 Sep 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 10 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LKN
- Device Class
- U
- Advisory Committee
- Unknown
- FDA Decision
- SESE Substantially Equivalent