X-AMYLASE ASSAY KIT
Device Facts
| Record ID | K852636 |
|---|---|
| Device Name | X-AMYLASE ASSAY KIT |
| Applicant | Diagnostic Chemicals, Ltd. (Usa) |
| Product Code | CIJ · Clinical Chemistry |
| Decision Date | Jul 12, 1985 |
| 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).
