K024031 is an FDA 510(k) clearance for the THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on February 6, 2003, 62 days after receiving the submission on December 6, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K024031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2002 |
| Decision Date | February 06, 2003 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |