K181514 is an FDA 510(k) clearance for the SeraQuest HSV Type 2 Specific 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 Quest International, Inc. (Palm City, US). The FDA issued a Cleared decision on June 13, 2019, 370 days after receiving the submission on June 8, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K181514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2018 |
| Decision Date | June 13, 2019 |
| Days to Decision | 370 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 |