K821097 is an FDA 510(k) clearance for the SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA..
Submitted by Icl Scientific (Walker, US). The FDA issued a Cleared decision on May 5, 1982, 15 days after receiving the submission on April 20, 1982.
This device falls under the Immunology FDA review panel.
| 510(k) Number | K821097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1982 |
| Decision Date | May 05, 1982 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | — |
| Device Class | — |