Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526
FDA 510(k) K010765 · Beckman Coulter, Inc.
510(k) numberK010765
Submission
- Device name
- Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526
- Applicant
- Beckman Coulter, Inc.
Miami, FL, US - Received
- March 14, 2001
- Decision date
- April 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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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 Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526 cleared by the FDA?
Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526 (K010765) received a 510(k) decision of Substantially Equivalent on April 13, 2001, 30 days after the submission was received.
What is the product code of K010765?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.