Sysmex Hematology System Accessories
FDA 510(k) K920544 · Toa Medical Electronics USA, Inc.
510(k) numberK920544
Submission
- Device name
- Sysmex Hematology System Accessories
- Applicant
- Toa Medical Electronics USA, Inc.
Los Alamitos, CA, US - Received
- February 6, 1992
- Decision date
- April 29, 1992
- 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 |
|---|---|---|
| K936023 | Sysmex SE-9000 Automated Hematology AnalyzerGKZ · Traditional | 05/02/1994SE |
| K933886 | Toa Medical Electronics CA-5000JPA · Traditional | 01/27/1994SE |
| K931149 | CA-1000 Automated Coagulation AnalyzerJPA · Traditional | 11/03/1993SE |
| K914744 | Sysmex NE-1500, ModificationGKZ · Traditional | 12/30/1991SE |
| K912494 | Sysmex(Tm) R-3000 Automated Reticulocyte AnalyzerGKL · Traditional | 09/10/1991SE |
| K911173 | Sysmex F-310GKL · Traditional | 07/26/1991SE |
| K911172 | Sysmex F-610GKL · Traditional | 07/26/1991SE |
| K910849 | Sysmex F-810GKL · Traditional | 07/26/1991SE |
| K910745 | Hemoglobin ReagentGKR · Traditional | 07/11/1991SE |
| K894539 | Sysmex R-1000 Automated Reticulocyte AnalyzerGKL · Traditional | 09/26/1989SE |
Questions and answers
When was Sysmex Hematology System Accessories cleared by the FDA?
Sysmex Hematology System Accessories (K920544) received a 510(k) decision of Substantially Equivalent on April 29, 1992, 83 days after the submission was received.
What is the product code of K920544?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.