K010855 is an FDA 510(k) clearance for the RANDOX IGE. This device is classified as a Ige, Antigen, Antiserum, Control (Class II - Special Controls, product code DGC).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, GB). The FDA issued a Cleared decision on May 15, 2001, 54 days after receiving the submission on March 22, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K010855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2001 |
| Decision Date | May 15, 2001 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DGC — Ige, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |