SENTINEL PLASMAPROTEINS CAL 3X— 510(k) K081533
Substantially EquivalentSENTINEL CH. SpA
FDA 510(k) clearance K081533 for SENTINEL PLASMAPROTEINS CAL 3X, Substantially Equivalent on 2008-06-25. Applicant: SENTINEL CH. SpA. Device class: 2.
Clearance details
- Applicant
- SENTINEL CH. SpA
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milan, IT
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More clearances from SENTINEL CH. SpA
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