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FDA 510(k)

Alegria Flash CTD Screen

K-Number: K250666 · 2025-10-22

ApplicantZeus Scientific
Decision Date2025-10-22
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Alegria Flash CTD Screen is a medical device manufactured by Zeus Scientific. It received FDA 510(k) clearance on 2025-10-22 under approval number K250666. 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 Alegria Flash CTD Screen?

Alegria Flash CTD Screen is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Zeus Scientific. The 510(k) number is K250666.

When was Alegria Flash CTD Screen approved by the FDA?

Alegria Flash CTD Screen received FDA 510(k) clearance on 2025-10-22, under approval number K250666.

What company makes Alegria Flash CTD Screen?

Alegria Flash CTD Screen is manufactured by Zeus Scientific.

What is the FDA product code for Alegria Flash CTD Screen?

The FDA product code for Alegria Flash CTD Screen is LLL.

Other Devices by Zeus Scientific

K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFine K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit K250408Alegria Flash ENA Screen K243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

Related Devices (Code: LLL)

K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsInova Diagnostics, Inc. K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc. K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc. K190710EliA SymphonyS ImmunoassayPhadia AB K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. K250408Alegria Flash ENA ScreenZeus Scientific

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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