Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)
FDA 510(k) K123677 · Siemens Healthcare Diagnostics
510(k) numberK123677
Submission
- Device name
- Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- November 30, 2012
- Decision date
- March 7, 2013
- 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 |
| 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 |
| K023841 | Ammonia Assay for the Advia 1650JIF · Traditional | Bayer Diagnostics Corp. | 12/24/2002SE |
| 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 |
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Questions and answers
When was Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal) cleared by the FDA?
Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal) (K123677) received a 510(k) decision of Substantially Equivalent on March 7, 2013, 97 days after the submission was received.
What is the product code of K123677?
The FDA product code is JIF – Enzymatic Method, Ammonia, a Class I (low risk) device regulated under 21 CFR 862.1065.