OPTIMATE HEMOGLOBIN A1C — Heraeus Kulzer, Inc. (510(k) K896830)
OPTIMATE HEMOGLOBIN A1C — Heraeus Kulzer, Inc. (510(k) K896830) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: OPTIMATE HEMOGLOBIN A1C; Applicant: Heraeus Kulzer, Inc.; Clearance track: 510(k).
| Device name | OPTIMATE HEMOGLOBIN A1C |
|---|---|
| Applicant | Heraeus Kulzer, Inc. |
| Clearance track | 510(k) |
| Submission number | K896830 |
| Decision | Substantially Equivalent |
| Decision date | 1990-09-11 |
| Date received | 1989-12-04 |
| Product code | LCP |
| Device class | 2 |
| Medical specialty | Hematology |
| Applicant location | IN, US |
| Source | openFDA device |
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$1999/mo
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