MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA — Roche Diagnostics Corp. (510(k) K042389)
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA — Roche Diagnostics Corp. (510(k) K042389) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA; Applicant: Roche Diag
| Device name | MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA |
|---|---|
| Applicant | Roche Diagnostics Corp. |
| Clearance track | 510(k) |
| Submission number | K042389 |
| Decision | Substantially Equivalent |
| Decision date | 2004-09-14 |
| Date received | 2004-09-02 |
| Product code | JJY |
| Device class | 1 |
| Medical specialty | Clinical Chemistry |
| Applicant location | IN, US |
| Source | openFDA device |
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