Sysmex Model Xt-4000I
510(k) K091313
Sysmex Model Xt-4000I is a Class II device made by Sysmex America, Inc., cleared under FDA 510(k) K091313 on 30 Mar 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091313 | Date30 Mar 2010 | StatusActive |
Official records
- FDA 510(k) database K091313
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GKZ
- Device class
- Class II
- Regulation
- 21 CFR Part 864.5220
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
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