FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
FDA 510(k) clearance K103450 · decided 2011-01-25
Clearance details
- K-number
- K103450
- Device name
- FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-24
- Decision date
- 2011-01-25
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Seguin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.