K081687 is an FDA 510(k) clearance for the LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG. This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II - Special Controls, product code MYF).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 10, 2008, 146 days after receiving the submission on June 17, 2008.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K081687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2008 |
| Decision Date | November 10, 2008 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |