K931806 is an FDA 510(k) clearance for the IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE. This device is classified as a Iga, Antigen, Antiserum, Control (Class II - Special Controls, product code CZP).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on July 16, 1993, 95 days after receiving the submission on April 12, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K931806 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1993 |
| Decision Date | July 16, 1993 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | CZP — Iga, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |