K051299 is an FDA 510(k) clearance for the IGD DIAGNOSTIC TEST KITS. This device is classified as a Igd, Antigen, Antiserum, Control (Class II - Special Controls, product code CZJ).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on November 23, 2005, 189 days after receiving the submission on May 18, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K051299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2005 |
| Decision Date | November 23, 2005 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | CZJ — Igd, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |