K062183 is an FDA 510(k) clearance for the FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT. This device is classified as a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II - Special Controls, product code LRM).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on November 21, 2006, 113 days after receiving the submission on July 31, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K062183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2006 |
| Decision Date | November 21, 2006 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |