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FDA 510(k)

EliA CTD 13 Screen

K-Number: K253367 · 2026-06-25

ApplicantPhadia AB
Decision Date2026-06-25
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EliA CTD 13 Screen is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253367. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EliA CTD 13 Screen?

EliA CTD 13 Screen is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Phadia AB. The 510(k) number is K253367.

When did EliA CTD 13 Screen receive FDA 510(k) clearance?

EliA CTD 13 Screen received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253367.

Who is the listed applicant for EliA CTD 13 Screen?

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 CTD 13 Screen?

The FDA product code for EliA CTD 13 Screen is LLL.

Other records listing Phadia AB as applicant

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Related Devices (Code: LLL)

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

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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