Additional Ims Assays for the Bayer Advia Ims System
FDA 510(k) K991817 · Bayer Corp.
510(k) numberK991817
Submission
- Device name
- Additional Ims Assays for the Bayer Advia Ims System
- Applicant
- Bayer Corp.
Tarrytown, NY, US - Received
- May 27, 1999
- Decision date
- July 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K024062 | Ascensia Breeze Blood Glucose MeterCGA · Traditional | 03/03/2003SE |
| K023944 | Bayer Diagnostics Clinitest Pregnancy TestJHI · Abbreviated | 02/11/2003SE |
| K024017 | Bayer Advia Centaur HER-2/NEU AssayNCW · Traditional | 01/30/2003SE |
| K024234 | Ascensia Glucofacts; Ascensia Glucofacts ProfessionalNBW · Traditional | 01/23/2003SE |
| K022288 | Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module…LTJ · Traditional | 12/17/2002SE |
| K023584 | Ascensia Dex 2 Diabetes Care SystemNBW · Special | 11/20/2002SE |
| K020828 | Ca 125 Assay for the Advia Centaur SystemLTK · Traditional | 07/24/2002SE |
| K021428 | Clinitek Atlas Pro 12 Reagent Pak SystemJFY · Traditional | 07/05/2002SE |
| K020806 | ACS:180 & Advia Centaur Afp ImmunoassayLOJ · Special | 03/27/2002SE |
| K013568 | Cea Assay for the Advia Integrated Modular SystemDHX · Traditional | 12/21/2001SE |
Questions and answers
When was Additional Ims Assays for the Bayer Advia Ims System cleared by the FDA?
Additional Ims Assays for the Bayer Advia Ims System (K991817) received a 510(k) decision of Substantially Equivalent on July 22, 1999, 56 days after the submission was received.
What is the product code of K991817?
The FDA product code is CIJ – Saccharogenic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.