HEMOGLOBIN REAGENT — Omega Medical Diagnostics (510(k) K831618)
HEMOGLOBIN REAGENT — Omega Medical Diagnostics (510(k) K831618) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: HEMOGLOBIN REAGENT; Applicant: Omega Medical Diagnostics; Clearance track: 510(k).
| Device name | HEMOGLOBIN REAGENT |
|---|---|
| Applicant | Omega Medical Diagnostics |
| Clearance track | 510(k) |
| Submission number | K831618 |
| Decision | Substantially Equivalent |
| Decision date | 1983-06-16 |
| Date received | 1983-05-19 |
| Product code | GKR |
| Device class | 2 |
| Medical specialty | Hematology |
| Applicant location | IL, US |
| Source | openFDA device |
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$1999/mo
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