ELECSYS CA 125 II CALSET — Roche Diagnostics Corp. (510(k) K003969)
ELECSYS CA 125 II CALSET — Roche Diagnostics Corp. (510(k) K003969) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ELECSYS CA 125 II CALSET; Applicant: Roche Diagnostics Corp.; Clearance track: 510(k).
| Device name | ELECSYS CA 125 II CALSET |
|---|---|
| Applicant | Roche Diagnostics Corp. |
| Clearance track | 510(k) |
| Submission number | K003969 |
| Decision | Substantially Equivalent |
| Decision date | 2001-01-12 |
| Date received | 2000-12-22 |
| Product code | JIS |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | IN, US |
| Source | openFDA device |
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