K940641 is an FDA 510(k) clearance for the ELIAS ANA TOTAL. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on March 25, 1994, 39 days after receiving the submission on February 14, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K940641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1994 |
| Decision Date | March 25, 1994 |
| Days to Decision | 39 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 |