ELECSYS CALCHECK CA 125II — Roche Diagnostics GmbH (510(k) K981278)
ELECSYS CALCHECK CA 125II — Roche Diagnostics GmbH (510(k) K981278) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ELECSYS CALCHECK CA 125II; Applicant: Roche Diagnostics GmbH; Clearance track: 510(k).
| Device name | ELECSYS CALCHECK CA 125II |
|---|---|
| Applicant | Roche Diagnostics GmbH |
| Clearance track | 510(k) |
| Submission number | K981278 |
| Decision | Substantially Equivalent |
| Decision date | 1998-04-23 |
| Date received | 1998-04-08 |
| Product code | JJX |
| Device class | 1 |
| Medical specialty | Clinical Chemistry |
| Applicant location | CA, US |
| Source | openFDA device |
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$1999/mo
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