K033802 is an FDA 510(k) clearance for the ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on February 27, 2004, 81 days after receiving the submission on December 8, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K033802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2003 |
| Decision Date | February 27, 2004 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |