K182098 is an FDA 510(k) clearance for the N Latex FLC kappa assay, N Latex FLC lambda assay. This device is classified as a Kappa, Antigen, Antiserum, Control (Class II - Special Controls, product code DFH).
Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on November 1, 2018, 90 days after receiving the submission on August 3, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K182098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2018 |
| Decision Date | November 01, 2018 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DFH — Kappa, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |