FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER CLONE MO2
K Number: K884605
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
16
Review Days
285
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Basic Information
- Device Name
- COULTER CLONE MO2
- K Number
- K884605
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Coulter Immunology
- Date Received
- November 3, 1988
- Decision Date
- August 15, 1989
- 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 Immunology
| K Number | Device Name | ||
|---|---|---|---|
| K922744 | CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 | Feb 5, 1993 | Substantially Equivalent |
| K922745 | CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 | Feb 5, 1993 | Substantially Equivalent |
| K910473 | CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC | Oct 31, 1991 | Substantially Equivalent |
| K911793 | COULTERCLONE | Jul 9, 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 |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | Aug 3, 1989 | Substantially Equivalent |
| K884020 | COULTER CLONE B4 MONOCLONAL ANTIBODY | Feb 3, 1989 | Substantially Equivalent |