Creatine Phosphokinase
FDA 510(k) K903775 · Amresco, Inc.
510(k) numberK903775
Submission
- Device name
- Creatine Phosphokinase
- Applicant
- Amresco, Inc.
Solon, OH, US - Received
- August 20, 1990
- Decision date
- October 4, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | Arkray, Inc. | 01/31/2006SE |
More from Arkray, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K905618 | GGT ReagentJPZ · Traditional | 02/26/1991SE |
| K904468 | Direct Bilirubin Reagent, 7776/7777/7576/7476/7176CIG · Traditional | 01/17/1991SE |
| K905684 | Alkaline PhosphataseCJE · Traditional | 12/28/1990SE |
| K905544 | Magnesium ReagentJGJ · Traditional | 12/27/1990SE |
| K905284 | Hdl-Cholesterol Precipitant 7773/7573/7473/7173LBR · Traditional | 12/11/1990SE |
| K904004 | Amrescocreat Kinase Reagent 7716/17,7516,7416,7116CGS · Traditional | 12/11/1990SE |
| K905096 | GGT Reagents, 7738, 7739, 7538, 7438 & 7138JQB · Traditional | 11/28/1990SE |
| K904381 | Diazo Colorimentry Direct BilirubinCIG · Traditional | 10/12/1990SE |
| K903829 | Ast ReagentCIT · Traditional | 09/25/1990SE |
| K904007 | Bicarbonate Reagents Amresco Product #4326020KHS · Traditional | 09/13/1990SE |
Questions and answers
When was Creatine Phosphokinase cleared by the FDA?
Creatine Phosphokinase (K903775) received a 510(k) decision of Substantially Equivalent on October 4, 1990, 45 days after the submission was received.
What is the product code of K903775?
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.