K171605 is an FDA 510(k) clearance for the Elecsys CA 15-3 II. This device is classified as a System, Test, Immunological, Antigen, Tumor (Class II - Special Controls, product code MOI).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 20, 2018, 264 days after receiving the submission on June 1, 2017.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K171605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2017 |
| Decision Date | February 20, 2018 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MOI — System, Test, Immunological, Antigen, Tumor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |