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

Substantially Equivalent

Zeus Scientific

Clearance details

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

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