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FDA 510(k)

Lp(a) Ultra

K-Number: K211058 · 2022-12-22

ApplicantSENTINEL CH. SpA
Decision Date2022-12-22
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Lp(a) Ultra is a medical device manufactured by SENTINEL CH. SpA. It received FDA 510(k) clearance on 2022-12-22 under approval number K211058. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lp(a) Ultra?

Lp(a) Ultra is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by SENTINEL CH. SpA. The 510(k) number is K211058.

When was Lp(a) Ultra approved by the FDA?

Lp(a) Ultra received FDA 510(k) clearance on 2022-12-22, under approval number K211058.

What company makes Lp(a) Ultra?

Lp(a) Ultra is manufactured by SENTINEL CH. SpA.

What is the FDA product code for Lp(a) Ultra?

The FDA product code for Lp(a) Ultra is DFC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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