FDA 510(k)

EliA Ro52, EliA Ro60

K-Number: K210902 · 2022-07-27

Decision Date2022-07-27

Product CodeLKJ

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

EliA Ro52, EliA Ro60 is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K210902. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EliA Ro52, EliA Ro60?

EliA Ro52, EliA Ro60 is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Phadia AB. The 510(k) number is K210902.

When did EliA Ro52, EliA Ro60 receive FDA 510(k) clearance?

EliA Ro52, EliA Ro60 received FDA 510(k) clearance on 2022-07-27, under 510(k) number K210902.

Who is the listed applicant for EliA Ro52, EliA Ro60?

The FDA 510(k) record lists Phadia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EliA Ro52, EliA Ro60?

The FDA product code for EliA Ro52, EliA Ro60 is LKJ.

Other records listing Phadia AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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