BUN (RATE) REAGENT — Sigma Diagnostics, Inc. (510(k) K850923)
BUN (RATE) REAGENT — Sigma Diagnostics, Inc. (510(k) K850923) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: BUN (RATE) REAGENT; Applicant: Sigma Diagnostics, Inc.; Clearance track: 510(k).
| Device name | BUN (RATE) REAGENT |
|---|---|
| Applicant | Sigma Diagnostics, Inc. |
| Clearance track | 510(k) |
| Submission number | K850923 |
| Decision | Substantially Equivalent |
| Decision date | 1985-03-20 |
| Date received | 1985-03-05 |
| Product code | CDQ |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | MO, US |
| Source | openFDA device |
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