K163569 is an FDA 510(k) clearance for the Elecsys CMV IgM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II - Special Controls, product code LFZ).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 17, 2017, 88 days after receiving the submission on December 19, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K163569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2016 |
| Decision Date | March 17, 2017 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |