510(k) K253212
- Device
- XR-Series (XR-10, XR-20) Automated Hematology Analyzers
- Applicant
- Sysmex America, Inc.
- 510(k) number
- K253212
- Product code
- GKZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-27
- Date received
- 2025-09-29
- Regulation
- 864.5220
- Classification name
- Counter, Differential Cell
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Yvonne Doswell
- Address
- 577 Aptakisic Rd. Lincolnshire IL US 60069 60069
FDA Registration Numbers#
- 1950302
- 3010960914
- 8040564
- 2919069
- 3004008703
- 3009711478
- 3016438761
- 3006412379
- 3005333358
- 3007750372
- 3006198300
- 1000292377
- 3007349751
- 3016090200
- 3009297077
- 1415939
- 3013059683
- 3002809144
- 1064608
- 2221819
- 3000148879
- 3013608230
- 3010421384
- 8020888
- 1036362
- 3003601075
- 3010324880
- 1181121
- 1832816
- 2914537
- 3014053517
- 3003423869
- 3002759288
- 9613959
- 3009156722
- 3003589956
- 3009092698
- 1221433
- 2032112
- 2182501
- 3008425728
- 3009189893
- 3013445220
- 8023018
- 3006946274
- 3006606827
- 1063851
- 1017835
- 3011765035
- 3038625004
- 1061932
- 3027394506
- 3007603826
- 3020704087
- 9610099
- 3009834076
- 3008096179
- 3039523350
- 3009495621
- 3008352382
- 3003630693
- 2432235
Source Documents#
Other 510(k) Records For Product Code GKZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243348 | Athelas Home | Athelas, Inc. | 2026-02-06 |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | 2026-01-16 |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | 2025-06-25 |
| K243283 | Alinity h-series System | Abbott Laboratories | 2025-02-20 |
| K240402 | Cito CBC System | Cytochip, Inc. | 2025-02-03 |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2024-07-05 |
| K232946 | Yumizen H2500 | HORIBA ABX SAS | 2024-05-21 |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies | 2024-05-02 |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | Sysmex America, Inc. | 2023-12-21 |
| K230878 | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | 2023-11-14 |
| K222148 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | 2023-08-16 |
| K220031 | Alinity h-series System | Abbott Laboratories | 2023-08-04 |
| K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | 2022-11-08 |
| K211840 | Sight OLO | S.D. Sight Diagnostics , Ltd. | 2022-05-09 |