K220178 is an FDA 510(k) clearance for the Total Immunoglobulin E (IgE). This device is classified as a Ige, Antigen, Antiserum, Control (Class II - Special Controls, product code DGC).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on March 23, 2022, 61 days after receiving the submission on January 21, 2022.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K220178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2022 |
| Decision Date | March 23, 2022 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| 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 |