K031563 is an FDA 510(k) clearance for the BINDAZYME CLQ CIC EIA KIT. This device is classified as a Complement C1q, Antigen, Antiserum, Control (Class II - Special Controls, product code DAK).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 10, 2003, 114 days after receiving the submission on May 19, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K031563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2003 |
| Decision Date | September 10, 2003 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DAK — Complement C1q, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |