SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
Device Facts
| Record ID | K860554 |
|---|---|
| Device Name | SERUM LIPASE REAGENT SET (TURBIDIMETRIC) |
| Applicant | Sterling Diagnostics, Inc. |
| Product Code | CFG · Clinical Chemistry |
| Decision Date | Mar 14, 1986 |
| 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.
