The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Farrzyme Human High Avidity Anti-dsdna Enzyme Immunoassay Kit.
| Device ID | K062183 |
| 510k Number | K062183 |
| Device Name: | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | THE BINDING SITE, LTD. 2425 W. OLYMPIC BLV Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. 2425 W. OLYMPIC BLV Santa Monica, CA 90404 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-11-21 |
| Summary: | summary |