K983422 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET. This device is classified as a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II - Special Controls, product code LRM).
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 | K983422 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 | LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |