CIJ · Saccharogenic, Amylase
Clinical Chemistry · 21 CFR 862.1070 · Class 2
Overview
| Product Code | CIJ |
|---|---|
| Device Name | Saccharogenic, 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 (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | Pointe Scientific, Inc., | Dec 23, 2002 | SESE |
| K991817 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | Jul 22, 1999 | SESE |
| K980013 | AMYLASE | Ac Biochemicals, Inc. | Feb 4, 1998 | SESE |
| K953211 | AMYLASE (ETHYLIDENE PNGPG7) KIT | Randox Laboratories, Ltd. | Jun 21, 1996 | SESE |
| K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | Emd Chemicals, Inc. | Dec 11, 1995 | SESE |
| K940735 | LIQUID AMYLASE (CNPG3) REAGENT SET | Pointe Scientific, Inc., | Aug 1, 1994 | SESE |
| K940010 | DMA AMYLASE (DEMAND) PROCEDURE | Data Medical Associates, Inc. | Mar 11, 1994 | SESE |
| K931301 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | Oct 18, 1993 | SESE |
| K931141 | BIOTROL AMYLASE CNPG3 | Biotrol, USA, Inc. | May 26, 1993 | SESE |
| K882225 | -AMYLASE EPS | Boehringer Mannheim Corp. | Jan 3, 1989 | SESE |
| K873572 | IL 35260, IL TEST AMYLASE REAGENT | Instrumentation Laboratory CO | Oct 20, 1987 | SESE |
| K873250 | ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL | Roche Diagnostic Systems, Inc. | Oct 20, 1987 | SESE |
| K872831 | BIOTROL ALPHA AMYLASE | Biotrol, USA, Inc. | Sep 4, 1987 | SESE |
| K871943 | D.A.T. (TM) AMYLASE REAGENT | Behring Diagnostics, Inc. | Jun 3, 1987 | SESE |
| K864356 | AMYLASE REAGENT | Trace Scientific , Ltd. | Jan 21, 1987 | SESE |
| K863719 | AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 | Technicon Instruments Corp. | Nov 13, 1986 | SESE |
| K862370 | DART AMYLASE-D.S. REAGENT SYSTEM | Coulter Electronics, Inc. | Aug 1, 1986 | SESE |
| K861664 | AMYLASE PROCEDURE | Data Medical Associates, Inc. | Jul 1, 1986 | SESE |
| K860935 | EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 | Em Diagnostic Systems, Inc. | May 23, 1986 | SESE |
| K853951 | ISOTRAK AMYLASE TEST AMYLASE ISOENZYME | Behring Diagnostics, Inc. | Jan 7, 1986 | SESE |
Top Applicants
- Harleco — 4 clearances
- Behring Diagnostics, Inc. — 2 clearances
- Biotrol, USA, Inc. — 2 clearances
- Coulter Electronics, Inc. — 2 clearances
- Data Medical Associates, Inc. — 2 clearances
