Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)— 510(k) K243776

Name: FDA 510(k) clearance K243776
Creator: U.S. Food and Drug Administration
Published: 2025-05-07

Substantially Equivalent

Zeus Scientific

FDA 510(k) clearance K243776 for Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed), Substantially Equivalent on 2025-05-07. Applicant: Zeus Scientific. Device class: 2.

Clearance details

Applicant: Zeus Scientific
Product code: Code MOB
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2024-12-09
Decision date: 2025-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOB

view all

K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM2026-08-21
K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern2018-05-24
K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin2018-03-23
K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay2018-03-13
K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit2017-02-03

More clearances from Zeus Scientific

view all

K250814 — Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB2026-05-08
K250666 — Alegria Flash CTD Screen2025-10-22
K250408 — Alegria Flash ENA Screen2025-09-19
K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine2023-08-31
K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit2023-07-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.