FACTOR V LEIDEN KIT
FDA 510(k) clearance DEN030005 · decided 2003-12-17
Clearance details
- K-number
- DEN030005
- Device name
- FACTOR V LEIDEN KIT
- Applicant
- Roche Diagnostics Corp.
- Decision
- Unknown
- Date received
- 2003-12-08
- Decision date
- 2003-12-17
- Days to decision
- 9 days
- Clearance type
- Post-NSE
- Product code
- NPQ
- Device class
- 2
- Regulation number
- 864.7280
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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