K983378 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on November 18, 1998, 54 days after receiving the submission on September 25, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K983378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1998 |
| Decision Date | November 18, 1998 |
| Days to Decision | 54 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 |