Lp(a) Ultra— 510(k) K211058

Substantially Equivalent

SENTINEL CH. SpA

FDA 510(k) clearance K211058 for Lp(a) Ultra, Substantially Equivalent on 2022-12-22. Applicant: SENTINEL CH. SpA.

Clearance details

Applicant: SENTINEL CH. SpA
Product code: Code DFC
Advisory panel: Immunology
Date received: 2021-04-09
Decision date: 2022-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

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