MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
Device Facts
| Record ID | K901858 |
|---|---|
| Device Name | MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | CET · Clinical Chemistry |
| Decision Date | Jun 12, 1990 |
| 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.
