K022018 is an FDA 510(k) clearance for the RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on July 5, 2002, 15 days after receiving the submission on June 20, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K022018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2002 |
| Decision Date | July 05, 2002 |
| Days to Decision | 15 days |
| Submission Type | Special |
| 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 |