K040111 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM. This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 5, 2004, 76 days after receiving the submission on January 20, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K040111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2004 |
| Decision Date | April 05, 2004 |
| Days to Decision | 76 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 |