K983426 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on November 18, 1998, 50 days after receiving the submission on September 29, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K983426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1998 |
| Decision Date | November 18, 1998 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |