WAKO AUTOKIT LIPASE-COLOR
Device Facts
| Record ID | K921249 |
|---|---|
| Device Name | WAKO AUTOKIT LIPASE-COLOR |
| Applicant | Wako Chemicals USA, Inc. |
| Product Code | CHI · Clinical Chemistry |
| Decision Date | Jul 21, 1992 |
| 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.
