CPK Reagent
FDA 510(k) K112416 · Vital Diagnostics (Manufacturing) Ptyltd
510(k) numberK112416
Submission
- Device name
- CPK Reagent
- Applicant
- Vital Diagnostics (Manufacturing) Ptyltd
Noble Park, AU - Received
- August 22, 2011
- Decision date
- November 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code CGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
More from Olympus America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K120626 | Eon Calcium RegentCJY · Traditional | 08/22/2012SE |
| K111063 | Vital Serum ControlsJJY · Traditional | 06/28/2011SE |
| K110394 | Atac Serum Calibrator (Direct Bilirubin and Iron)JIX · Abbreviated | 06/09/2011SE |
| K100060 | Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475KHS · Traditional | 12/15/2010SE |
Questions and answers
When was CPK Reagent cleared by the FDA?
CPK Reagent (K112416) received a 510(k) decision of Substantially Equivalent on November 9, 2011, 79 days after the submission was received.
What is the product code of K112416?
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.