K061820 is an FDA 510(k) clearance for the DIASORIN LIAISON 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 February 26, 2007, 243 days after receiving the submission on June 28, 2006.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3900.
| 510(k) Number | K061820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2006 |
| Decision Date | February 26, 2007 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| 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 |