FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION
FDA 510(k) clearance K093724 · decided 2010-07-29
Clearance details
- K-number
- K093724
- Device name
- FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION
- Applicant
- Taidoc Technology Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-12-03
- Decision date
- 2010-07-29
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.