LIPASE-PS ASSAY PROCEDURE NO. 805
Device Facts
| Record ID | K941085 |
|---|---|
| Device Name | LIPASE-PS ASSAY PROCEDURE NO. 805 |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | CHI · Clinical Chemistry |
| Decision Date | May 17, 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.
