Creatine Kinase-Mb (Ck-Mb) Reagent Set
FDA 510(k) K915709 · Tech Intl. Co.
510(k) numberK915709
Submission
- Device name
- Creatine Kinase-Mb (Ck-Mb) Reagent Set
- Applicant
- Tech Intl. Co.
Rochester Hills, MI, US - Received
- November 29, 1991
- Decision date
- January 27, 1992
- 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 |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | Arkray, Inc. | 01/31/2006SE |
More from Arkray, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915704 | Amylase (Kinetic) Reagent SetCJD · Traditional | 06/28/1996SE |
| K915705 | Acid Phosphatase Reagent SetCKE · Traditional | 02/27/1992SE |
| K915707 | Ammonia Reagent SetJIF · Traditional | 02/26/1992SE |
| K914158 | Uric Acid Reagent SetKNK · Traditional | 02/21/1992SE |
| K915706 | Lipase Reagent SetCET · Traditional | 02/18/1992SE |
| K915710 | Amylase (Colorimetric) Reagent SetJFJ · Traditional | 01/30/1992SE |
| K914160 | Cholesterol Regeant SetCHH · Traditional | 01/30/1992SE |
| K914159 | Glucose Reagent SetCGA · Traditional | 01/27/1992SE |
| K915708 | Inorganic Phosphorus(Colorimetric) Reagent SetCEO · Traditional | 01/22/1992SE |
| K914171 | In Vitro Diagnostic Regeant Set,CholinesteraseDIH · Traditional | 12/18/1991SE |
Questions and answers
When was Creatine Kinase-Mb (Ck-Mb) Reagent Set cleared by the FDA?
Creatine Kinase-Mb (Ck-Mb) Reagent Set (K915709) received a 510(k) decision of Substantially Equivalent on January 27, 1992, 59 days after the submission was received.
What is the product code of K915709?
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.