K992449 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA. This device is classified as a System, Test, Anticardiolipin Immunological (Class II - Special Controls, product code MID).
Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on November 24, 1999, 125 days after receiving the submission on July 22, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K992449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1999 |
| Decision Date | November 24, 1999 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MID — System, Test, Anticardiolipin Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |