K952567 is an FDA 510(k) clearance for the AUTOSTATTMII ANTI-DSDNA. This device is classified as a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II - Special Controls, product code LRM).
Submitted by Cogent Diagnotics , Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on March 4, 1997, 638 days after receiving the submission on June 5, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K952567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1995 |
| Decision Date | March 04, 1997 |
| Days to Decision | 638 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |