K243776 is an FDA 510(k) clearance for the Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed). This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on May 7, 2025, 149 days after receiving the submission on December 9, 2024.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K243776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2024 |
| Decision Date | May 07, 2025 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MOB - Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |