Cardiozyme Plus Ck-Total Item #65046 (a)
FDA 510(k) K811576 · Harleco
510(k) numberK811576
Submission
- Device name
- Cardiozyme Plus Ck-Total Item #65046 (a)
- Applicant
- Harleco
Mchenry, IL, US - Received
- June 4, 1981
- Decision date
- June 25, 1981
- 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 |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Cardiozyme Plus Ck-Total Item #65046 (a) cleared by the FDA?
Cardiozyme Plus Ck-Total Item #65046 (a) (K811576) received a 510(k) decision of Substantially Equivalent on June 25, 1981, 21 days after the submission was received.
What is the product code of K811576?
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.