Ammonia Assay for the Advia 1650
FDA 510(k) K023841 · Bayer Diagnostics Corp.
510(k) numberK023841
Submission
- Device name
- Ammonia Assay for the Advia 1650
- Applicant
- Bayer Diagnostics Corp.
Tarrytown, NY, US - Received
- November 18, 2002
- Decision date
- December 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIF – Enzymatic Method, Ammonia
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1065
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K183517 | Ammonia IIJIF · Traditional | Roche Diagnostics Operations (Rdo) | 02/08/2019SE |
| K123677 | Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)JIF · Traditional | Siemens Healthcare Diagnostics | 03/07/2013SE |
| K123320 | Dimension Ammonia Flex Reagent CartridgeJIF · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K062316 | Dimension Vista Ammonia (Amon) Flex Reagent CartridgeJIF · Special | Dade Behring, Inc. | 09/06/2006SE |
| K051114 | Sentinel Ammonia Ultra Diagnostic AssayJIF · Traditional | Sentinel Ch. Srl | 11/25/2005SE |
| K033921 | AMMONIA-L3K Assay, Catalogue Number 233-10JIF · Traditional | Diagnostic Chemicals , Ltd. | 03/10/2004SE |
| K030873 | Randox AmmoniaJIF · Traditional | Randox Laboratories, Ltd. | 05/12/2003SE |
| K021151 | Ammonia Assay for the Advia Integrated Modular SystemJIF · Traditional | Bayer Diagnostics Corp. | 07/13/2002SE |
| K003196 | Synchron Systems Ammonia ReagentJIF · Traditional | Beckman Coulter, Inc. | 12/22/2000SE |
| K001285 | AMMONIA-L3K Assay, Model 263-17, AMMONIA-L3K Assay, Model 263-30JIF · Traditional | Diagnostic Chemicals , Ltd. | 06/02/2000SE |
More from Diagnostic Chemicals , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K033379 | Bayer Special Chemistry ControlsJJY · Abbreviated | 12/19/2003SE |
| K033380 | Bayer Special Chemistry CalibratorsJIX · Abbreviated | 12/16/2003SE |
| K033007 | Bayer Advia Digoxin Assay for the Integrated Module SystemKXT · Traditional | 11/14/2003SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | 09/04/2003SE |
| K022096 | Uric Acid Assay for the Advia Integrated Modular SystemKNK · Traditional | 03/18/2003SE |
| K030452 | Bayer Ligand Plus 1, 2, 3 ControlsJJY · Abbreviated | 03/03/2003SE |
| K023840 | Acid Phosphatase Assay for the Advia 1650CKB · Traditional | 01/07/2003SE |
| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional | 12/17/2002SE |
| K022329 | Ca 125 II Assay for the Bayer Advia Integrated Module SystemLTK · Traditional | 11/27/2002SE |
| K023184 | Ethanol Assay for the Bayer Advia Integrated Module SystemDIC · Traditional | 11/18/2002SE |
Questions and answers
When was Ammonia Assay for the Advia 1650 cleared by the FDA?
Ammonia Assay for the Advia 1650 (K023841) received a 510(k) decision of Substantially Equivalent on December 24, 2002, 36 days after the submission was received.
What is the product code of K023841?
The FDA product code is JIF – Enzymatic Method, Ammonia, a Class I (low risk) device regulated under 21 CFR 862.1065.