-Amylase Eps
FDA 510(k) K882225 · Boehringer Mannheim Corp.
510(k) numberK882225
Submission
- Device name
- -Amylase Eps
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- May 26, 1988
- Decision date
- January 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIJ – Saccharogenic, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIJ
| 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 |
| K873572 | Il 35260, Il Test Amylase ReagentCIJ · Traditional | Instrumentation Laboratory CO | 10/20/1987SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was -Amylase Eps cleared by the FDA?
-Amylase Eps (K882225) received a 510(k) decision of Substantially Equivalent on January 3, 1989, 222 days after the submission was received.
What is the product code of K882225?
The FDA product code is CIJ – Saccharogenic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.