K993557 is an FDA 510(k) clearance for the AUTOSTAT II RHEUMATOID FACTOR IGA ELISA. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on March 3, 2000, 135 days after receiving the submission on October 20, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K993557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1999 |
| Decision Date | March 03, 2000 |
| Days to Decision | 135 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 |