Spotchem II Inoganic Phosphorus, CPK and Uric Acid Tests
FDA 510(k) K051648 · Arkray, Inc.
510(k) numberK051648
Submission
- Device name
- Spotchem II Inoganic Phosphorus, CPK and Uric Acid Tests
- Applicant
- Arkray, Inc.
Cortlandt Manor, NY, US - Received
- June 21, 2005
- Decision date
- January 31, 2006
- 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 |
| K112416 | CPK ReagentCGS · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 11/09/2011SE |
| 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 |
| K043202 | Olympus Creatine Kinase Reagent OSR6179/OSR6279CGS · Traditional | Olympus America, Inc. | 12/23/2004SE |
More from Olympus America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis SystemLKM · Traditional | 05/03/2024SE |
| K193514 | AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional | 04/13/2023SE |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL · Traditional | 10/17/2022SE |
| K200788 | Assure Titanium Blood Glucose Monitoring SystemPZI · Dual Track | 05/23/2022SE |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional | 10/07/2016SE |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional | 02/01/2013SE |
| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | 12/23/2009SE |
| K053401 | Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional | 03/24/2006SE |
| K051432 | Spotchem II Total Bilirubin, Total Protein and Albumin TestsCIG · Traditional | 06/17/2005SE |
| K050790 | Spotchem II LDH TestCFH · Traditional | 06/06/2005SE |
Questions and answers
When was Spotchem II Inoganic Phosphorus, CPK and Uric Acid Tests cleared by the FDA?
Spotchem II Inoganic Phosphorus, CPK and Uric Acid Tests (K051648) received a 510(k) decision of Substantially Equivalent on January 31, 2006, 224 days after the submission was received.
What is the product code of K051648?
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.