ELECSYS LH CALCHECK 5 — Roche Diagnostics (510(k) K121279)
ELECSYS LH CALCHECK 5 — Roche Diagnostics (510(k) K121279) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ELECSYS LH CALCHECK 5; Applicant: Roche Diagnostics; Clearance track: 510(k).
| Device name | ELECSYS LH CALCHECK 5 |
|---|---|
| Applicant | Roche Diagnostics |
| Clearance track | 510(k) |
| Submission number | K121279 |
| Decision | Substantially Equivalent |
| Decision date | 2012-05-10 |
| Date received | 2012-04-30 |
| Product code | JJX |
| Device class | 1 |
| Medical specialty | Clinical Chemistry |
| Applicant location | IN, US |
| Source | openFDA device |
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$1999/mo
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