510(k) K260781
K260781 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "Yumizen H550". The FDA issued a decision of Substantially Equivalent on September 14, 2026. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2026
- Date Received
- March 10, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type