K221114 is an FDA 510(k) clearance for the Immunoglobulin G (IgG). This device is classified as a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II - Special Controls, product code CFN).
Submitted by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 2, 2023, 474 days after receiving the submission on April 15, 2022.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K221114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2022 |
| Decision Date | August 02, 2023 |
| Days to Decision | 474 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CFN - Method, Nephelometric, Immunoglobulins (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |