DCA VANTAGE, MODEL 5075
FDA 510(k) clearance K071466 · decided 2007-10-09
Clearance details
- K-number
- K071466
- Device name
- DCA VANTAGE, MODEL 5075
- Applicant
- Siemens Medical Solutions Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2007-05-29
- Decision date
- 2007-10-09
- Days to decision
- 133 days
- Clearance type
- Special
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Norowood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.