ACCURATE I — Organon, Inc. (510(k) K812261)
ACCURATE I — Organon, Inc. (510(k) K812261) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ACCURATE I; Applicant: Organon, Inc.; Clearance track: 510(k).
| Device name | ACCURATE I |
|---|---|
| Applicant | Organon, Inc. |
| Clearance track | 510(k) |
| Submission number | K812261 |
| Decision | Substantially Equivalent |
| Decision date | 1981-08-31 |
| Date received | 1981-08-12 |
| Product code | JHJ |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | MI, US |
| Source | openFDA device |
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$1999/mo
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