| K-number | K821879 |
| Device name | ULTRACHEM T.P. |
| Applicant | Harleco Diagnostics |
| Product code | CEX |
| Device class | Class II |
| Decision date | Jul 14, 1982 |
| Decision | Substantially Equivalent |
| Regulation | 862.1445 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov