Submission Details
| 510(k) Number | K033802 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
Feb 2004
Decision
81d
Days
Class 2
Risk
About This 510(k) Submission
K033802 is an FDA 510(k) clearance for the ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM, 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 review panel. Regulated under 21 CFR 866.5775.
Device Classification
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5775 |
Manufacturer
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