ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
Device Facts
| Record ID | K923917 |
|---|---|
| Device Name | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY |
| Applicant | Nuclear Diagnostics, Inc. |
| Product Code | CHI · Clinical Chemistry |
| Decision Date | Feb 25, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1465 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
