Contour Next Control Solution
FDA 510(k) K151742 · Bayer Healthcare
510(k) numberK151742
Submission
- Device name
- Contour Next Control Solution
- Applicant
- Bayer Healthcare
Mishawaka, IN, US - Received
- June 29, 2015
- Decision date
- September 23, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Decision |
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| K150942 | Contour Next USB Blood Glucose Monitoring SystemNBW · Special | 11/25/2015SE |
| K130265 | Contour Next Ez Blood Glucose MeterNBW · Traditional | 06/23/2014SE |
| K122370 | Contour Next Link Wireless Blood Glucose MonitorNBW · Traditional | 09/26/2013SE |
| K121190 | Contour Next Blood Glucose MeterLFR · Special | 07/26/2012SE |
| K121087 | Contour Next Usb Blood Glucose Monitoring SystemNBW · Special | 06/28/2012SE |
| K110894 | Contour Next Link Wireless Blood Glucose MeterLFR · Traditional | 03/28/2012SE |
| K110587 | Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…LFR · Traditional | 03/28/2012SE |
| K111268 | Contour (R) Next Blood Glucose Monitoring SystemLFR · Traditional | 03/06/2012SE |
Questions and answers
When was Contour Next Control Solution cleared by the FDA?
Contour Next Control Solution (K151742) received a 510(k) decision of Substantially Equivalent on September 23, 2015, 86 days after the submission was received.
What is the product code of K151742?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.