INDIKO
FDA 510(k) clearance K110035 · decided 2011-06-28
Clearance details
- K-number
- K110035
- Device name
- INDIKO
- Applicant
- Thermofisher Scientific OY
- Decision
- Substantially Equivalent
- Date received
- 2011-01-05
- Decision date
- 2011-06-28
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Vantaa, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.