K233663 is an FDA 510(k) clearance for the N Antisera to Human Immunoglobulins (IgG, IgA, and IgM). This device is classified as a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II - Special Controls, product code CFN).
Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on December 13, 2023, 28 days after receiving the submission on November 15, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K233663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |