CJA · Amyloclastic, Amylase
Clinical Chemistry · 21 CFR 862.1070 · Class 2
Overview
| Product Code | CJA |
|---|---|
| Device Name | Amyloclastic, 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K895555 | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) | Hichem Diagnostics | Dec 22, 1989 | SESE |
| K884226 | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | A-Kem, Inc. | Dec 9, 1988 | SESE |
| K883059 | WAKO(TM) AUTOKIT AMYLASE | Wako Chemicals USA, Inc. | Aug 30, 1988 | SESE |
| K873520 | PARAMAX AMYLASE REAGENT | Baxter Healthcare Corp | Nov 23, 1987 | SESE |
| K863052 | ALPHA AMYLASE | J. D. Assoc. | Sep 9, 1986 | SESE |
| K862640 | AMYLASE LTS | Electro-Nucleonics Laboratories, Inc. | Sep 9, 1986 | SESE |
| K860530 | AMYLASE REAGENT SET (MODIFIED CARAWAY) | Sterling Diagnostics, Inc. | Feb 28, 1986 | SESE |
| K844168 | AMYLASE REAGENT CS-726 | Fisher Scientific Co., LLC | Nov 20, 1984 | SESE |
| K843529 | ASTRA SYSTEMS AMYLASE REAGENT KIT | Beckman Instruments, Inc. | Oct 11, 1984 | SESE |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | Sterling Biochemical, Inc. | Jan 13, 1984 | SESE |
Top Applicants
- A-Kem, Inc. — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Electro-Nucleonics Laboratories, Inc. — 1 clearance
- Fisher Scientific Co., LLC — 1 clearance
