FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER Z2 ANALYZER
K Number: K991070
·
Decision May 11, 1999
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
51
Review Days
41
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COULTER Z2 ANALYZER
- K Number
- K991070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coulter Corp.
- Date Received
- March 31, 1999
- Decision Date
- May 11, 1999
- Product Code
- GKL
- 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKL), ordered by most recent decision date.
Glocyte Automated Cell Counter System
FDA 510(k)
FDA Class 2
·Hematology
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
FDA 510(k)
FDA Class 2
·Hematology
HEMOCUE WBC SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
FDA 510(k)
FDA Class 2
·Hematology
SYSMEX POCH-100I
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Coulter Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K993356 | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES | Apr 20, 2000 | 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 |
| K971469 | COULTER ACT TRON CELL CONTROL | Jun 30, 1997 | Substantially Equivalent |