CardioChek Plus Test System
FDA 510(k) K151530 · Polymer Technology Systems, Inc.
510(k) numberK151530
Submission
- Device name
- CardioChek Plus Test System
- Applicant
- Polymer Technology Systems, Inc.
Indianapolis, IN, US - Received
- June 8, 2015
- Decision date
- July 7, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | 12/22/2016SE |
| K140068 | Cardiochek Plus Test System, Cardiochek Home Test SystemNBW · Special | 05/22/2015SE |
| K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…CGA · Traditional | 10/02/2014SE |
| K071593 | PTS Panels Chol+Hdl Panel Test StripsCHH · Special | 10/15/2007SE |
| K071507 | PTS Panels Chol+Hdl+Glu Panel Test StripsNBW · Special | 09/10/2007SE |
| K070017 | PTS Panels Metabolic Chemistry Panel Test StripsNBW · Special | 01/31/2007SE |
| K060617 | PTS Panels HDL Cholesterol Test StripsNAQ · Special | 04/05/2006SE |
| K041750 | PTS Panels Chol+Glu Test PanelNBW · Special | 07/23/2004SE |
| K040693 | PTS Panels LDL Cholesterol Test StripsMRR · Traditional | 07/06/2004SE |
| K023558 | PTS Panels Lipid Panel Test StripsCHH · Special | 11/15/2002SE |
Questions and answers
When was CardioChek Plus Test System cleared by the FDA?
CardioChek Plus Test System (K151530) received a 510(k) decision of Substantially Equivalent on July 7, 2015, 29 days after the submission was received.
What is the product code of K151530?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.