Cleared Traditional

Lp(a) Ultra

K211058 · SENTINEL CH. SpA · Chemistry
Dec 2022
Decision
622d
Days
Class 2
Risk

About This 510(k) Submission

K211058 is an FDA 510(k) clearance for the Lp(a) Ultra, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on December 22, 2022, 622 days after receiving the submission on April 9, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K211058 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2021
Decision Date December 22, 2022
Days to Decision 622 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5600

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