| K-number | K813042 |
| Device name | ULTRACHEM GLUC-DH SET, ITEM #65048 |
| Applicant | Harleco |
| Product code | LFR |
| Device class | Class II |
| Decision date | Nov 10, 1981 |
| Decision | Substantially Equivalent |
| Regulation | 862.1345 |
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