Roche Diagnostics · Class I · Cleared Aug 24, 2012
| K-number | K121895 |
| Device name | ELECSYS HSV-2 IGG IMMUNOASSAY |
| Applicant | Roche Diagnostics |
| Product code | JJX |
| Device class | Class I |
| Decision date | Aug 24, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
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