CJD · Nitrosalicylate Reduction, Amylase
Clinical Chemistry · 21 CFR 862.1070 · Class 2
Overview
| Product Code | CJD |
|---|---|
| Device Name | Nitrosalicylate Reduction, Amylase |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K915704 | AMYLASE (KINETIC) REAGENT SET | Tech Intl. Co. | Jun 28, 1996 | SESE |
Top Applicants
- Tech Intl. Co. — 1 clearance
