Sysmex XE-2100, Automatated Hematology Analyzer
FDA 510(k) K992875 · Sysmex Corp.
510(k) numberK992875
Submission
- Device name
- Sysmex XE-2100, Automatated Hematology Analyzer
- Applicant
- Sysmex Corp.
Long Grove, IL, US - Received
- August 26, 1999
- Decision date
- November 9, 1999
- 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 |
| K232946 | Yumizen H2500GKZ · Traditional | Horiba Abx SAS | 05/21/2024SE |
| K240636 | HemoScreen Hematology AnalyzerGKZ · Abbreviated | Pixcell Medical Technologies | 05/02/2024SE |
More from Pixcell Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K012372 | Sysmex UF-50LKM · Traditional | 09/28/2001SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | 11/03/1998SE |
| K981761 | Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional | 08/14/1998SE |
| K971736 | Sysmex Immature Reticulocyte Fraction (Irf) ParameterGKZ · Traditional | 08/26/1997SE |
| K964946 | Sysmex CA-1000/SYSMEX CA-5000JPA · Traditional | 03/18/1997SE |
| K964375 | Sysmex SE/RAM-1GKL · Traditional | 03/13/1997SE |
| K961054 | Sysmex UF-100LKM · Traditional | 10/28/1996SE |
| K950508 | Sysmex SF-3000FPK · Traditional | 11/03/1995SE |
| K945837 | Sysmex(Tm) F-820, 520GKZ · Traditional | 06/09/1995SE |
| K942097 | Toa Medical Electronics CA-5000JPA · Traditional | 03/24/1995SE |
Questions and answers
When was Sysmex XE-2100, Automatated Hematology Analyzer cleared by the FDA?
Sysmex XE-2100, Automatated Hematology Analyzer (K992875) received a 510(k) decision of Substantially Equivalent on November 9, 1999, 75 days after the submission was received.
What is the product code of K992875?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.