K920087 is an FDA 510(k) clearance for the IGE EIA TEST KIT. This device is classified as a Ige, Peroxidase, Antigen, Antiserum, Control (Class II - Special Controls, product code DGO).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on September 14, 1992, 250 days after receiving the submission on January 8, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K920087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 1992 |
| Decision Date | September 14, 1992 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DGO — Ige, Peroxidase, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |