AMYLASE TEST (AMYL) ITEM NUMBER: 65653
Device Facts
| Record ID | K884382 |
|---|---|
| Device Name | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | CIW · Clinical Chemistry |
| Decision Date | Jan 11, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
