510(k) clearances

Yumizen H2500

HORIBA ABX SAS · Hematology

K232946Substantially EquivalentTraditionalGKZ
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
2024-05-21
Decision code
SESE
Country code
FR
Device name
Yumizen H2500
Advisory committee
HE
Contact
Caroline Ferrer
K number
K232946
Date received
2023-09-20
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
3004008703, 1036362, 3010421384, 3007113174, 3010960914, 3007349751, 3006412379, 2432235, 3005146313, 3009297077, 3016090200, 1064608, 3006946274, 1000292377, 3000148879, 3003589956, 3003630693, 3003423869, 3003601075, 3006198300, 3014053517, 3009495621, 1221433, 1017835, 3007603826, 8023018, 8020888, 3010324880, 2032112, 3002809144, 3002759288, 3008352382, 3009711478, 3009189893, 1181121, 3038625004, 3013445220, 3008096179, 9610099, 1950302 +22 more
FEI number
3004008703, 1036362, 3010421384, 3002807272, 3007113174, 3010960914, 3007349751, 3006412379, 3002806778, 2432235, 3005146313, 3009297077, 3016090200, 3006946274, 1000292377, 3000148879, 3003589956, 6137, 3003630693, 3003423869, 3003601075, 3006198300, 3014053517, 3009495621, 1221433, 1017835, 3007603826, 3010324880, 3002809144, 3002759288, 3008352382, 3009711478, 3009189893, 1181121, 3038625004, 3013445220, 3008096179, 1950302, 3008425728, 3039523350 +22 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.