K983465 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE. This device is classified as a Anti-rnp Antibody, Antigen And Control (Class II - Special Controls, product code LKO).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on November 18, 1998, 48 days after receiving the submission on October 1, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K983465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1998 |
| Decision Date | November 18, 1998 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKO — Anti-rnp Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |