| K-number | K760024 |
| Device name | ULTRAZYME ALKALINE PHOSPHATASE |
| Applicant | Harleco |
| Product code | CJE |
| Device class | Class II |
| Decision date | Aug 26, 1976 |
| Decision | Substantially Equivalent |
| Regulation | 862.1050 |
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