FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
K Number: K963263
·
Decision Jan 22, 1997
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
376
Applicant Total
51
Review Days
155
Basic Information
- Device Name
- TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
- K Number
- K963263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COULTER CORP.
- Date Received
- August 20, 1996
- Decision Date
- January 22, 1997
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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Other Clearances by COULTER CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K993356 | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES | Apr 20, 2000 | Substantially Equivalent |
| K991070 | COULTER Z2 ANALYZER | May 11, 1999 | Substantially Equivalent |
| K990327 | RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS | Apr 26, 1999 | Substantially Equivalent |
| K990172 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA | Apr 13, 1999 | Substantially Equivalent |
| K990352 | COULTER AC T DIFF 2 ANALYZER | Apr 1, 1999 | Substantially Equivalent |
| K984216 | IMMUNO-TROL CONTROL CELLS | Mar 16, 1999 | Substantially Equivalent |
| K982167 | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | Nov 9, 1998 | Substantially Equivalent |
| K982166 | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | Nov 5, 1998 | Substantially Equivalent |
| K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL | Sep 24, 1998 | Substantially Equivalent |
| K973634 | COULTER AC.T DIFF ANALYZER | Oct 29, 1997 | Substantially Equivalent |