TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5— 510(k) K963263
Substantially EquivalentCoulter Corp.
FDA 510(k) clearance K963263 for TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5, Substantially Equivalent on 1997-01-22. Applicant: Coulter Corp.. Device class: 2.
Clearance details
- Applicant
- Coulter Corp.
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code GKZ
view allMore clearances from Coulter Corp.
view all- K993356 — COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
- K991070 — COULTER Z2 ANALYZER
- K990327 — RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
- K990172 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
- K990352 — COULTER AC T DIFF 2 ANALYZER
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K963263
K-number listed on FDA's recall record- Z-0472-2019 — COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963263.
Data sourced from openFDA. This site is unofficial and independent of the FDA.