K131334 is an FDA 510(k) clearance for the HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST. This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II - Special Controls, product code MXJ).
Submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on February 28, 2014, 295 days after receiving the submission on May 9, 2013.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K131334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2013 |
| Decision Date | February 28, 2014 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MXJ - Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |