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FDA 510(k)

Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM

K-Number: K261466 · 2026-08-21

ApplicantZeus Scientific
Decision Date2026-08-21
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2026-08-21 under 510(k) number K261466. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM?

Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Zeus Scientific. The 510(k) number is K261466.

When did Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM receive FDA 510(k) clearance?

Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM received FDA 510(k) clearance on 2026-08-21, under 510(k) number K261466.

Who is the listed applicant for Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM?

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 MPO; Alegria Flash PR3; Alegria Flash GBM?

The FDA product code for Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM is MOB.

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 ScreenK250408Alegria Flash ENA 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 Kit

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Related Devices (Code: MOB)

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.

K243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc.K172461AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinAesku.Diagnostics GmbH & Co. KGK173792EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova 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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