Lp(a) Ultra— 510(k) K211058
Substantially EquivalentSENTINEL CH. SpA
FDA 510(k) clearance K211058 for Lp(a) Ultra, Substantially Equivalent on 2022-12-22. Applicant: SENTINEL CH. SpA. Device class: 2.
Clearance details
- Applicant
- SENTINEL CH. SpA
- Product code
- Code DFC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5600
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milan, IT
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More clearances from SENTINEL CH. SpA
view allData sourced from openFDA. This site is unofficial and independent of the FDA.