Cell-Dyn 1400 Multi-Parameter Automated Hematology
FDA 510(k) K903665 · Unipath , Ltd.
510(k) numberK903665
Submission
- Device name
- Cell-Dyn 1400 Multi-Parameter Automated Hematology
- Applicant
- Unipath , Ltd.
Mountain View, CA, US - Received
- August 15, 1990
- Decision date
- October 4, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
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|---|---|---|---|
| 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 |
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Questions and answers
When was Cell-Dyn 1400 Multi-Parameter Automated Hematology cleared by the FDA?
Cell-Dyn 1400 Multi-Parameter Automated Hematology (K903665) received a 510(k) decision of Substantially Equivalent on October 4, 1990, 50 days after the submission was received.
What is the product code of K903665?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.