K120625 is an FDA 510(k) clearance for the ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV. This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II - Special Controls, product code MXJ).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 25, 2012, 146 days after receiving the submission on March 1, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K120625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2012 |
| Decision Date | July 25, 2012 |
| Days to Decision | 146 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 |