FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
K Number: K060423
·
Decision Aug 15, 2006
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
2
Review Days
179
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Basic Information
- Device Name
- CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
- K Number
- K060423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dakocytomation California, Inc.
- Date Received
- February 17, 2006
- Decision Date
- August 15, 2006
- 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 Dakocytomation California, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT | Feb 15, 2005 | Substantially Equivalent |