FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTERCLONE
K Number: K911793
·
Decision Jul 9, 1991
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
376
Applicant Total
16
Review Days
78
Basic Information
- Device Name
- COULTERCLONE
- K Number
- K911793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- COULTER IMMUNOLOGY
- Date Received
- April 22, 1991
- Decision Date
- July 9, 1991
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKZ), ordered by most recent decision date.
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
FDA 510(k)
FDA Class 2
·Hematology
Alinity h-series System
FDA 510(k)
FDA Class 2
·Hematology
Cito CBC System
FDA 510(k)
FDA Class 2
·Hematology
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
FDA 510(k)
FDA Class 2
·Hematology
Yumizen H2500
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by COULTER IMMUNOLOGY
| K Number | Device Name | ||
|---|---|---|---|
| K922745 | CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 | Feb 5, 1993 | Substantially Equivalent |
| K922744 | CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 | Feb 5, 1993 | Substantially Equivalent |
| K910473 | CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC | Oct 31, 1991 | Substantially Equivalent |
| K893853 | COULTER CLONE T8 MONOCLONAL ANTIBODY | Mar 2, 1990 | Substantially Equivalent |
| K893852 | COULTER CLONE T4 MONOCLONAL ANTIBODY | Mar 2, 1990 | Substantially Equivalent |
| K894179 | COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY | Feb 12, 1990 | Substantially Equivalent |
| K895917 | CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI | Dec 29, 1989 | Substantially Equivalent |
| K884605 | COULTER CLONE MO2 | Aug 15, 1989 | Substantially Equivalent |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | Aug 3, 1989 | Substantially Equivalent |
| K883753 | COULTER CLONE T1 MONOCLONAL ANTIBODY | Feb 3, 1989 | Substantially Equivalent |