K930247 is an FDA 510(k) clearance for the HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE. This device is classified as a System, Test, Systemic Lupus Erythematosus (Class II - Special Controls, product code DHC).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on March 10, 1993, 50 days after receiving the submission on January 19, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5820.
| 510(k) Number | K930247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1993 |
| Decision Date | March 10, 1993 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DHC — System, Test, Systemic Lupus Erythematosus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5820 |