VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
FDA 510(k) clearance K060227 · decided 2006-05-25
Clearance details
- K-number
- K060227
- Device name
- VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
- Applicant
- Vision Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-30
- Decision date
- 2006-05-25
- Days to decision
- 115 days
- Clearance type
- Abbreviated
- Product code
- MYA
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Norwell, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.