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FDA 510(k)

Alegria Flash ENA Screen

K-Number: K250408 · 2025-09-19

ApplicantZeus Scientific
Decision Date2025-09-19
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Alegria Flash ENA Screen is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250408. 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 ENA Screen?

Alegria Flash ENA Screen is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Zeus Scientific. The 510(k) number is K250408.

When did Alegria Flash ENA Screen receive FDA 510(k) clearance?

Alegria Flash ENA Screen received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250408.

Who is the listed applicant for Alegria Flash ENA Screen?

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

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

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

Other records listing Zeus Scientific 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.

K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBK250666Alegria Flash CTD ScreenK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineK230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitK201956Zeus IFA ANA HEp-2 Test System, Zeus dIFine

View all 12 devices →

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.

K253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia ABK180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsInova Diagnostics, Inc.

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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