AMYLASE 405 CATALOG NUMBER 301-34
Device Facts
| Record ID | K880867 |
|---|---|
| Device Name | AMYLASE 405 CATALOG NUMBER 301-34 |
| Applicant | Diagnostic Chemicals, Ltd. (Usa) |
| Product Code | JFJ · Clinical Chemistry |
| Decision Date | Apr 19, 1988 |
| 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).
