AMYLASE REAGENT SET (MODIFIED CARAWAY)
Device Facts
| Record ID | K860530 |
|---|---|
| Device Name | AMYLASE REAGENT SET (MODIFIED CARAWAY) |
| Applicant | Sterling Diagnostics, Inc. |
| Product Code | CJA · Clinical Chemistry |
| Decision Date | Feb 28, 1986 |
| 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).
