Yumizen H2500
FDA 510(k) K232946 · Horiba Abx SAS
510(k) numberK232946
Submission
- Device name
- Yumizen H2500
- Applicant
- Horiba Abx SAS
Montpellier, FR - Received
- September 20, 2023
- Decision date
- May 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
Other 510(k)s with product code GKZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | Sysmex America, Inc. | 05/27/2026SE |
| K243348 | Athelas HomeGKZ · Traditional | Athelas, Inc. | 02/06/2026SE |
| K251249 | Tru Hematology TestGKZ · Traditional | Truvian Sciences, Inc. | 01/16/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | Abbott Laboratories | 02/20/2025SE |
| K240402 | Cito CBC SystemGKZ · Dual Track | Cytochip, Inc. | 02/03/2025SE |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional | Beckman Coulter, Inc. | 07/05/2024SE |
| K240636 | HemoScreen Hematology AnalyzerGKZ · Abbreviated | Pixcell Medical Technologies | 05/02/2024SE |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 12/21/2023SE |
More from Sysmex America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K193649 | Yumizen C1200 Creatinine PAPJFY · Traditional | 05/10/2021SE |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…CZP · Traditional | 06/26/2020SE |
| K192028 | Yumizen C1200 CRPDCK · Traditional | 06/25/2020SE |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF · Traditional | 03/06/2020SE |
| K191993 | Yumizen C1200 CRPDCK · Traditional | 10/03/2019SE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE · Traditional | 08/30/2019SE |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJY · Traditional | 07/26/2019SE |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CTGKZ · Traditional | 11/01/2017SE |
| K151133 | Pentra XLRGKZ · Traditional | 12/09/2015SE |
| K141161 | Abx Micros Es 60 CT; (Open Tube Model), (Close Tube Model)GKZ · Traditional | 12/20/2014SE |
Questions and answers
When was Yumizen H2500 cleared by the FDA?
Yumizen H2500 (K232946) received a 510(k) decision of Substantially Equivalent on May 21, 2024, 244 days after the submission was received.
What is the product code of K232946?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.