KHM · Nephelometric, Amylase
Clinical Chemistry · 21 CFR 862.1070 · Class 2
Overview
| Product Code | KHM |
|---|---|
| Device Name | Nephelometric, 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831295 | AMYLASE REAGENT #88129 | Hi Chem, Inc. | Jun 30, 1983 | SESE |
| K812699 | AMYLASE | Pointe Scientific, Inc., | Oct 6, 1981 | SESE |
| K812447 | AMYLASE REAGENT KIT | Bioscientific | Sep 9, 1981 | SESE |
| K801096 | PERKIN ELMER MODEL 91 AMYLASE REAGENT | Stat Engineering | Jun 9, 1980 | SESE |
| K790797 | AMYLASE REAGENT SET | Alta Diagnostics, Inc. | Jul 17, 1979 | SESE |
| K770400 | REAGENT, AMYLASE LIPASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 26, 1977 | SESE |
Top Applicants
- Alta Diagnostics, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bioscientific — 1 clearance
- Hi Chem, Inc. — 1 clearance
- Pointe Scientific, Inc., — 1 clearance
