K162969 is an FDA 510(k) clearance for the LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II - Special Controls, product code LFZ).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on January 6, 2017, 74 days after receiving the submission on October 24, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K162969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2016 |
| Decision Date | January 06, 2017 |
| Days to Decision | 74 days |
| Submission Type | Special |
| 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 |