Randox Liquid Ck-Mb, Randox Ck-Mb Calibrator
FDA 510(k) K123977 · Randox Laboratories, Ltd.
510(k) numberK123977
Submission
- Device name
- Randox Liquid Ck-Mb, Randox Ck-Mb Calibrator
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- December 26, 2012
- Decision date
- November 21, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K083465 | Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine…CGS · Special | Siemens Healthcare Diagnostics | 02/27/2009SE |
| 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 Randox Liquid Ck-Mb, Randox Ck-Mb Calibrator cleared by the FDA?
Randox Liquid Ck-Mb, Randox Ck-Mb Calibrator (K123977) received a 510(k) decision of Substantially Equivalent on November 21, 2013, 330 days after the submission was received.
What is the product code of K123977?
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.