FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
K Number: K883836
·
Decision Nov 30, 1988
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
16
Review Days
79
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Basic Information
- Device Name
- COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
- K Number
- K883836
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Coulter Immunology
- Date Received
- September 12, 1988
- Decision Date
- November 30, 1988
- Product Code
- GGK
- 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 |
|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | FDA class 1 | 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 |
| K884605 | COULTER CLONE MO2 | Aug 15, 1989 | Substantially Equivalent |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | Aug 3, 1989 | Substantially Equivalent |