Yumizen H550
HORIBA ABX SAS · Hematology
Open FDA's page for this record- Third party flag
- N
- City
- Montpellier
- Advisory committee description
- Hematology
- Address 1
- Parc Euromedecine
- Address 2
- Rue Du Caducee Bp7290
- Statement or summary
- Summary
- Product code
- GKZ
- Zip code
- 34184
- Applicant
- HORIBA ABX SAS
- Decision date
- 2026-09-14
- Decision code
- SESE
- Country code
- FR
- Device name
- Yumizen H550
- Advisory committee
- HE
- Contact
- Christelle Calvo
- K number
- K260781
- Date received
- 2026-03-10
- Review advisory committee
- HE
- Postal code
- 34184
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Counter, Differential Cell
- Medical specialty description
- Hematology
- Regulation number
- 864.5220
- Device class
- 2
- Registration number
- 8040564, 3016438761, 3027394506, 3007750372, 3006412379, 3008352382, 3038625004, 1017835, 3011765035, 3010324880, 3006606827, 2032112, 1221433, 3013059683, 3009189893, 2182501, 3009495621, 3010421384, 1063851, 2919069, 8020888, 3010960914, 1036362, 3009156722, 8023018, 3014053517, 3002809144, 3008425728, 3020704087, 3013608230, 1181121, 2432235, 1061932, 3003423869, 3007113174, 1064608, 9610099, 9613959, 3006946274, 1000292377 +24 more
- FEI number
- 3016438761, 3027394506, 3007750372, 3006412379, 3002806778, 3008352382, 3038625004, 1017835, 3011765035, 3010324880, 3006606827, 1221433, 3013059683, 3009189893, 2182501, 3009495621, 3010421384, 2919069, 3010960914, 1036362, 3009156722, 6137, 3014053517, 3002809144, 3003071743, 3008425728, 3002807272, 3020704087, 3013608230, 3003076831, 3007019572, 1181121, 2432235, 3003423869, 3007113174, 3007603826, 3006946274, 1000292377, 3009834076, 1000442352 +24 more