REAGENT, AMYLASE LIPASE
Device Facts
| Record ID | K770400 |
|---|---|
| Device Name | REAGENT, AMYLASE LIPASE |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | KHM · Clinical Chemistry |
| Decision Date | Apr 26, 1977 |
| 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).
