ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY — Roche Diagnostics (510(k) K131605)
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY — Roche Diagnostics (510(k) K131605) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY; Applicant: Roche Diagnostics; Clearance track: 510(k).
| Device name | ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY |
|---|---|
| Applicant | Roche Diagnostics |
| Clearance track | 510(k) |
| Submission number | K131605 |
| Decision | Substantially Equivalent |
| Decision date | 2014-02-28 |
| Date received | 2013-06-03 |
| Product code | LFZ |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | IN, US |
| Source | openFDA device |
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