Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer
FDA 510(k) K913305 · Unipath , Ltd.
510(k) numberK913305
Submission
- Device name
- Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer
- Applicant
- Unipath , Ltd.
Mountain View, CA, US - Received
- July 25, 1991
- Decision date
- November 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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 |
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| 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 3000A Multi-Parameter Auto Hema Analzyer cleared by the FDA?
Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer (K913305) received a 510(k) decision of Substantially Equivalent on November 22, 1991, 120 days after the submission was received.
What is the product code of K913305?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.