Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase MB Flex Reagent Cartridge
FDA 510(k) K083465 · Siemens Healthcare Diagnostics
510(k) numberK083465
Submission
- Device name
- Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase MB Flex Reagent Cartridge
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- November 24, 2008
- Decision date
- February 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent SetCGS · Traditional | Medtest DX | 08/11/2020SE |
| K182702 | SEKURE Creatine Kinase AssayCGS · Traditional | Sekisui Diagnostics P.E.I., Inc. | 04/17/2019SE |
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorCGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/07/2016SE |
| K123977 | Randox Liquid Ck-Mb, Randox Ck-Mb CalibratorCGS · Traditional | Randox Laboratories, Ltd. | 11/21/2013SE |
| K112416 | CPK ReagentCGS · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 11/09/2011SE |
| K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…CGS · Traditional | Siemens Healthcare Diagnostics | 08/29/2008SE |
| K072548 | Creatine Kinase Liquid Reagent, Model C519-440CGS · Traditional | Teco Diagnostics | 04/18/2008SE |
| K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerCGS · Traditional | Horiba Abx | 06/12/2007SE |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | Arkray, Inc. | 01/31/2006SE |
| K043202 | Olympus Creatine Kinase Reagent OSR6179/OSR6279CGS · Traditional | Olympus America, Inc. | 12/23/2004SE |
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Questions and answers
When was Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase MB Flex Reagent Cartridge cleared by the FDA?
Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase MB Flex Reagent Cartridge (K083465) received a 510(k) decision of Substantially Equivalent on February 27, 2009, 95 days after the submission was received.
What is the product code of K083465?
The FDA product code is CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.