MODIFICATION TO SENTINEL CLIN CHEM CAL
FDA 510(k) clearance K070971 · decided 2007-05-23
Clearance details
- K-number
- K070971
- Device name
- MODIFICATION TO SENTINEL CLIN CHEM CAL
- Applicant
- Sentinel Ch. Srl
- Decision
- Substantially Equivalent
- Date received
- 2007-04-06
- Decision date
- 2007-05-23
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milan, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.