K231151 is an FDA 510(k) clearance for the Kenota 1 Total IgE. This device is classified as a Ige, Antigen, Antiserum, Control (Class II - Special Controls, product code DGC).
Submitted by Kenota, Inc. (Kitchener, CA). The FDA issued a Cleared decision on May 31, 2024, 403 days after receiving the submission on April 24, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K231151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2023 |
| Decision Date | May 31, 2024 |
| Days to Decision | 403 days |
| Submission Type | Dual Track |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DGC - Ige, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |