Advia Ims
FDA 510(k) K001344 · Bayer Corp.
510(k) numberK001344
Submission
- Device name
- Advia Ims
- Applicant
- Bayer Corp.
Tarrytown, NY, US - Received
- April 27, 2000
- Decision date
- June 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIH – Colorimetry, Cholinesterase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3240
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K103373 | Synchron Systems Cholinesterase (Chex) Model A53722DIH · Traditional | Beckman Coulter, Inc. | 02/07/2011SE |
| K061093 | Cholinesterase GEN.2 Test SystemDIH · Traditional | Roche Diagnostics Corp. | 07/03/2006SE |
| K051444 | Sentinel Cholinesterase LiquidDIH · Special | Sentinel Ch. Srl | 06/20/2005SE |
| K030045 | Olympus Cholinesterase Reagent (Catalog Number OSR6114)DIH · Traditional | Olympus America, Inc. | 02/21/2003SE |
| K023992 | Wiener Lab Colinesterasa AaDIH · Traditional | Wiener Laboratories Saic | 02/12/2003SE |
| K013750 | Advia 1650 Cholinesterase AssayDIH · Traditional | Bayer Diagnostics Corp. | 01/18/2002SE |
| K002792 | Careside CholinesteraseDIH · Traditional | Careside, Inc. | 11/08/2000SE |
| K961656 | Test-Mate Che Cholinesterase Test SystemDIH · Traditional | Eqm Research, Inc. | 11/26/1996SE |
| K943367 | Il Test CholinesteraseDIH · Traditional | Instrumentation Laboratory CO | 02/05/1996SE |
| K955498 | Cholinesterase Assay Kit, Catalogue# 300-05DIH · Traditional | Diagnostic Chemicals , Ltd. | 01/24/1996SE |
More from Diagnostic Chemicals , Ltd.
| 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 Advia Ims cleared by the FDA?
Advia Ims (K001344) received a 510(k) decision of Substantially Equivalent on June 26, 2000, 60 days after the submission was received.
What is the product code of K001344?
The FDA product code is DIH – Colorimetry, Cholinesterase, a Class I (low risk) device regulated under 21 CFR 862.3240.