CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
FDA 510(k) K151545 · Polymer Technology Systems, Inc.
510(k) numberK151545
Submission
- Device name
- CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
- Applicant
- Polymer Technology Systems, Inc.
Indianapolis, IN, US - Received
- June 9, 2015
- Decision date
- December 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251091 | LipidsCHH · Traditional | Truvian Health | 12/30/2025SE |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional | Medicon Hellas S.A | 08/09/2024SE |
| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
| K181373 | Extended Lipid Panel AssayCHH · Traditional | Laboratory Corporation of America Holdings | 10/18/2018SE |
| K180504 | Mission Lipid Panel Monitoring SystemCHH · Special | ACON Laboratories, Inc. | 03/28/2018SE |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional | ACON Laboratories, Inc. | 07/11/2017SE |
| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
| K130200 | Piccolo Total Cholesterol - Capillary Test SystemCHH · Traditional | Abaxis, Inc. | 02/15/2013SE |
More from Abaxis, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151530 | CardioChek Plus Test SystemCGA · Traditional | 07/07/2015SE |
| 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, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System cleared by the FDA?
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (K151545) received a 510(k) decision of Substantially Equivalent on December 22, 2016, 562 days after the submission was received.
What is the product code of K151545?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.