Atac Pak CPK Reagent Kit
FDA 510(k) K012474 · Elan Holdings, Inc.
510(k) numberK012474
Submission
- Device name
- Atac Pak CPK Reagent Kit
- Applicant
- Elan Holdings, Inc.
Brea, CA, US - Received
- August 2, 2001
- Decision date
- October 3, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K013152 | Atac Pak Direct HDL Reagent and Atac Direct HDL Calibrator KitsLBS · Traditional | 11/09/2001SE |
| K010488 | Atac Pak Ast Reagent KitCIT · Traditional | 04/09/2001SE |
| K000958 | Atac Pak Bun Reagent and Atac Calibrator KitsCDQ · Traditional | 05/24/2000SE |
| K000900 | Atac Pak Cholesterol Reagent and Atac Callibrator KitsCHH · Traditional | 05/02/2000SE |
| K992844 | Hichem Ise Electrolyte BufferJGS · Traditional | 11/26/1999SE |
| K992842 | Hichem Ise Electrolyte ReferenceJGS · Traditional | 11/26/1999SE |
| K992846 | Hichem Total Protein ReagentCEK · Traditional | 10/18/1999SE |
| K992845 | Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration…JIX · Traditional | 10/18/1999SE |
| K992847 | Hichem Bun ReagentLFP · Traditional | 10/14/1999SE |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | 07/09/1999SE |
Questions and answers
When was Atac Pak CPK Reagent Kit cleared by the FDA?
Atac Pak CPK Reagent Kit (K012474) received a 510(k) decision of Substantially Equivalent on October 3, 2001, 62 days after the submission was received.
What is the product code of K012474?
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.