K150375 is an FDA 510(k) clearance for the LIAISON VZV IgG, LIAISON Control VZV IgG. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II - Special Controls, product code LFY).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on March 11, 2015, 26 days after receiving the submission on February 13, 2015.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K150375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2015 |
| Decision Date | March 11, 2015 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3900 |