K941409 is an FDA 510(k) clearance for the ENA PROFILE-6 ELISA TEST SYSTEM. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on June 10, 1994, 79 days after receiving the submission on March 23, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K941409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1994 |
| Decision Date | June 10, 1994 |
| Days to Decision | 79 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 |