THE CARDIAC READER SYSTEM — Roche Diagnostics Corp. (510(k) K000784)
THE CARDIAC READER SYSTEM — Roche Diagnostics Corp. (510(k) K000784) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: THE CARDIAC READER SYSTEM; Applicant: Roche Diagnostics Corp.; Clearance track: 510(k).
| Device name | THE CARDIAC READER SYSTEM |
|---|---|
| Applicant | Roche Diagnostics Corp. |
| Clearance track | 510(k) |
| Submission number | K000784 |
| Decision | Substantially Equivalent |
| Decision date | 2000-05-18 |
| Date received | 2000-03-10 |
| Product code | MMI |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | NY, US |
| Source | openFDA device |
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$1999/mo
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