Coulter Hematology Analyzers with Irf & MRV Analyses
FDA 510(k) K993356 · Coulter Corp.
510(k) numberK993356
Submission
- Device name
- Coulter Hematology Analyzers with Irf & MRV Analyses
- Applicant
- Coulter Corp.
Miami, FL, US - Received
- October 6, 1999
- Decision date
- April 20, 2000
- 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 |
|---|---|---|
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | 05/11/1999SE |
| K990327 | Reticone System for Epics XL Flow Cytometry SystemsGKZ · Traditional | 04/26/1999SE |
| K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…GKZ · Traditional | 04/13/1999SE |
| K990352 | Coulter Ac T Diff 2 AnalyzerGKZ · Traditional | 04/01/1999SE |
| K984216 | Immuno-Trol Control CellsJPK · Traditional | 03/16/1999SE |
| K982167 | Cyto-Stat Trichrome CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | 11/09/1998SE |
| K982166 | Cyto-Stat Trichrome CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | 11/05/1998SE |
| K982172 | Cyto-Stat CD3-FITC/CD56-RDI Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone…GKZ · Traditional | 09/24/1998SE |
| K973634 | Coulter Ac.T Diff AnalyzerGKZ · Traditional | 10/29/1997SE |
| K971469 | Coulter Act Tron Cell ControlJPK · Traditional | 06/30/1997SE |
Questions and answers
When was Coulter Hematology Analyzers with Irf & MRV Analyses cleared by the FDA?
Coulter Hematology Analyzers with Irf & MRV Analyses (K993356) received a 510(k) decision of Substantially Equivalent on April 20, 2000, 197 days after the submission was received.
What is the product code of K993356?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.