CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
FDA 510(k) clearance K060423 · decided 2006-08-15
Clearance details
- K-number
- K060423
- Device name
- CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
- Applicant
- Dakocytomation California, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-17
- Decision date
- 2006-08-15
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.