Creatine Kinase for Manual/Automated Applications
FDA 510(k) K894715 · Catachem, Inc.
510(k) numberK894715
Submission
- Device name
- Creatine Kinase for Manual/Automated Applications
- Applicant
- Catachem, Inc.
Port Chester, NY, US - Received
- July 25, 1989
- Decision date
- November 8, 1989
- 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 |
|---|---|---|
| K062503 | Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test KitKWW · Traditional | 01/19/2007SE |
| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | 02/22/1995SE |
| K932871 | Uibc for Discreet Random Access AnalyzerCFM · Traditional | 09/08/1993SE |
| K903341 | MagnesiumJGJ · Traditional | 08/22/1990SE |
| K902326 | Amylase for Manual/Automated ApplicationsJFJ · Traditional | 07/31/1990SE |
| K902877 | Total Iron for Manual/AutomatedJIY · Traditional | 07/27/1990SE |
| K895748 | Bicarbonate for Manual/Automated ApplicationsKHS · Traditional | 12/21/1989SE |
| K895821 | Uric Acid for Manual/Automated ApplicationsKNK · Traditional | 12/05/1989SE |
| K894476 | Calcium (Arsenazo III) for Manual/Auto ApplicationCJY · Traditional | 10/12/1989SE |
| K894389 | Creatinine for Manual or Automated ApplicationsGGX · Traditional | 10/12/1989SE |
Questions and answers
When was Creatine Kinase for Manual/Automated Applications cleared by the FDA?
Creatine Kinase for Manual/Automated Applications (K894715) received a 510(k) decision of Substantially Equivalent on November 8, 1989, 106 days after the submission was received.
What is the product code of K894715?
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.