| K-number | K812500 |
| Device name | ULTRACHEM URIC ACID ALDH, ITEM #65047 |
| Applicant | Harleco |
| Product code | CDO |
| Device class | Class I |
| Decision date | Sep 23, 1981 |
| Decision | Substantially Equivalent |
| Regulation | 862.1775 |
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