Saccharogenic, Amylase
FDA product code CIJ · Class II (moderate risk) · 21 CFR 862.1070 · Clinical Chemistry
31510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Harleco 4
- Pointe Scientific, Inc., 2
- Coulter Electronics, Inc. 2
- Em Diagnostic Systems, Inc. 2
- Behring Diagnostics, Inc. 2
- Data Medical Associates, Inc. 2
- Biotrol, USA, Inc. 2
- Technicon Instruments Corp. 1
- Bayer Corp. 1
- Randox Laboratories, Ltd. 1
- Emd Chemicals, Inc. 1
- Olympus Corp. 1
- Boehringer Mannheim Corp. 1
- Instrumentation Laboratory CO 1
- Roche Diagnostic Systems, Inc. 1
- Trace Scientific , Ltd. 1
- Diagnostic Chemicals, Ltd. (Usa) 1
- American Dade 1
- General Diagnostics 1
- Worthington Diagnostic Systems 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023396 | Amylase EPS-G7 (Liquid) Reagent Set, (Hitachi Analyzers)CIJ · Traditional | Pointe Scientific, Inc., | 12/23/2002SE |
| K991817 | Additional Ims Assays for the Bayer Advia Ims SystemCIJ · Traditional | Bayer Corp. | 07/22/1999SE |
| K980013 | AmylaseCIJ · Traditional | Ac Biochemicals, Inc. | 02/04/1998SE |
| K953211 | Amylase (Ethylidene PNGPG7) KitCIJ · Traditional | Randox Laboratories, Ltd. | 06/21/1996SE |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | Emd Chemicals, Inc. | 12/11/1995SE |
| K940735 | Liquid Amylase (CNPG3) Reagent SetCIJ · Traditional | Pointe Scientific, Inc., | 08/01/1994SE |
| K940010 | Dma Amylase (Demand) ProcedureCIJ · Traditional | Data Medical Associates, Inc. | 03/11/1994SE |
| K931301 | Olympus Amylase ReagentCIJ · Traditional | Olympus Corp. | 10/18/1993SE |
| K931141 | Biotrol Amylase CNPG3CIJ · Traditional | Biotrol, USA, Inc. | 05/26/1993SE |
| K882225 | -Amylase EpsCIJ · Traditional | Boehringer Mannheim Corp. | 01/03/1989SE |
| K873572 | Il 35260, Il Test Amylase ReagentCIJ · Traditional | Instrumentation Laboratory CO | 10/20/1987SE |
| K873250 | Isomune-Amylase and Isomune-Amylase ControlCIJ · Traditional | Roche Diagnostic Systems, Inc. | 10/20/1987SE |
| K872831 | Biotrol Alpha AmylaseCIJ · Traditional | Biotrol, USA, Inc. | 09/04/1987SE |
| K871943 | D.A.T. (TM) Amylase ReagentCIJ · Traditional | Behring Diagnostics, Inc. | 06/03/1987SE |
| K864356 | Amylase ReagentCIJ · Traditional | Trace Scientific , Ltd. | 01/21/1987SE |
| K863719 | Amylase,Calcium,Chloride & Triglycerides on Chem 1CIJ · Traditional | Technicon Instruments Corp. | 11/13/1986SE |
| K862370 | Dart Amylase-D.S. Reagent SystemCIJ · Traditional | Coulter Electronics, Inc. | 08/01/1986SE |
| K861664 | Amylase ProcedureCIJ · Traditional | Data Medical Associates, Inc. | 07/01/1986SE |
| K860935 | Emds Amylase (Amyl) Test Packs, # 67653/95CIJ · Traditional | Em Diagnostic Systems, Inc. | 05/23/1986SE |
| K853951 | Isotrak Amylase Test Amylase IsoenzymeCIJ · Traditional | Behring Diagnostics, Inc. | 01/07/1986SE |
| K852636 | X-Amylase Assay KitCIJ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/12/1985SE |
| K843645 | Systemate a Amylase Hem 67204CIJ · Traditional | Em Diagnostic Systems, Inc. | 09/28/1984SE |
| K834053 | Dart Alpha-Amylase Reagent SystemCIJ · Traditional | Coulter Electronics, Inc. | 02/04/1984SE |
| K813529 | Dade Colorimetric AmylaseCIJ · Traditional | American Dade | 12/31/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | Harleco | 10/02/1981SE |
| K792479 | Chem-Strate AmylaseCIJ · Traditional | General Diagnostics | 12/27/1979SE |
| K790474 | Szamyl 6.5CIJ · Traditional | Worthington Diagnostic Systems | 05/01/1979SE |
| K780513 | Ultra Zyme Plus Amyl 64982, Gilford 3500CIJ · Traditional | Harleco | 05/19/1978SE |
| K780141 | Ultrazyme Plus Amyl, Centrifichem Appli.CIJ · Traditional | Harleco | 03/09/1978SE |
| K760415 | Enzymatic Amylase Reagent KitCIJ · Traditional | Beckman Instruments, Inc. | 11/05/1976SE |
| K760026 | Ultrazyme AmylaseCIJ · Traditional | Harleco | 09/21/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2923-2020 Class II | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 ReagentAmylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted… | Randox Laboratories, Ltd. | 07/10/2020Terminated |