| K-number | K802842 |
| Device name | SINGLE VIAL LIPASE TEST KIT |
| Applicant | Biodynamics Corp. |
| Product code | CHI |
| Device class | Class I |
| Decision date | Dec 18, 1980 |
| Decision | Substantially Equivalent |
| Regulation | 862.1465 |
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