Cardiochek Plus Test System, Cardiochek Home Test System
FDA 510(k) K140068 · Polymer Technology Systems, Inc.
510(k) numberK140068
Submission
- Device name
- Cardiochek Plus Test System, Cardiochek Home Test System
- Applicant
- Polymer Technology Systems, Inc.
Indianapolis, IN, US - Received
- January 13, 2014
- Decision date
- May 22, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NBW
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|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
More from Ascensia Diabetes Care
| 510(k) | Device | Decision |
|---|---|---|
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | 12/22/2016SE |
| K151530 | CardioChek Plus Test SystemCGA · Traditional | 07/07/2015SE |
| 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 cleared by the FDA?
Cardiochek Plus Test System, Cardiochek Home Test System (K140068) received a 510(k) decision of Substantially Equivalent on May 22, 2015, 494 days after the submission was received.
What is the product code of K140068?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.