SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
Device Facts
| Record ID | K903332 |
|---|---|
| Device Name | SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | JFJ · Clinical Chemistry |
| Decision Date | Aug 17, 1990 |
| 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).
