Coulter(R) MH010
FDA 510(k) K911385 · Coulter Electronics, Inc.
510(k) numberK911385
Submission
- Device name
- Coulter(R) MH010
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- March 28, 1991
- Decision date
- June 17, 1991
- 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
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 |
|---|---|---|
| K923951 | CD8 Cytospheres KitMAM · Traditional | 04/25/1994SE |
| K930119 | Coulter Retic-C Cell ControlJPK · Traditional | 04/05/1993SE |
| K921279 | CD4 Cytospheres KitGKZ · Traditional | 12/29/1992SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | 10/14/1992SE |
| K922181 | Coulter MH009GKZ · Traditional | 08/17/1992SE |
| K922704 | Coulter Maxm W/ AutoloaderGKZ · Traditional | 07/27/1992SE |
| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | 07/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
| K905767 | Coulter Dart Alt (GPT) ReagentCKA · Traditional | 01/25/1991SE |
Questions and answers
When was Coulter(R) MH010 cleared by the FDA?
Coulter(R) MH010 (K911385) received a 510(k) decision of Substantially Equivalent on June 17, 1991, 81 days after the submission was received.
What is the product code of K911385?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.