510(k) clearance
Yumizen H550
- 510(k) number
- K260781
- Applicant
- HORIBA ABX SAS
- Decision date
- Sep 14, 2026
- Date received
- Mar 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GKZ
- Device type
- Counter, Differential Cell
- Device class
- Class II
- Regulation
- 21 CFR 864.5220
- Advisory committee
- Hematology
- Statement or summary
- Summary
- Third party
- N
- Location
- Montpellier, FR