K243776
- 510(k) number
- K243776
- Device name
- Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- Applicant
- Zeus Scientific NJ · US
- Product code
- MOB — Test System, Antineutrophil Cytoplasmic Antibodies (
- Decision date
- 2025-05-07
- Date received
- 2024-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243776
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.