Alegria Flash CTD Screen— 510(k) K250666
Substantially EquivalentZeus Scientific
FDA 510(k) clearance K250666 for Alegria Flash CTD Screen, Substantially Equivalent on 2025-10-22. Applicant: Zeus Scientific. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific
- Product code
- Code LLL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Recent devices under product code LLL
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view all- K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
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- K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
- K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.