LIPASE FLEX REAGENT CARTRIDGE
Device Facts
| Record ID | K952816 |
|---|---|
| Device Name | LIPASE FLEX REAGENT CARTRIDGE |
| Applicant | Dupont Medical Products |
| Product Code | CHI · Clinical Chemistry |
| Decision Date | Jul 20, 1995 |
| 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.
