FACTOR II (PROTHROMBIN) G20210A KIT
FDA 510(k) clearance K033612 · decided 2003-12-18
Clearance details
- K-number
- K033612
- Device name
- FACTOR II (PROTHROMBIN) G20210A KIT
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-17
- Decision date
- 2003-12-18
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- NPR
- 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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|---|---|---|
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