COAGUCHEK XS SYSTEM — Roche Diagnostics Corp. (510(k) K062925)
COAGUCHEK XS SYSTEM — Roche Diagnostics Corp. (510(k) K062925) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: COAGUCHEK XS SYSTEM; Applicant: Roche Diagnostics Corp.; Clearance track: 510(k).
| Device name | COAGUCHEK XS SYSTEM |
|---|---|
| Applicant | Roche Diagnostics Corp. |
| Clearance track | 510(k) |
| Submission number | K062925 |
| Decision | Substantially Equivalent |
| Decision date | 2007-01-29 |
| Date received | 2006-09-28 |
| Product code | GJS |
| Device class | 2 |
| Medical specialty | Hematology |
| Applicant location | IN, US |
| Source | openFDA device |
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$1999/mo
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