The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour Next Control Solution.
| Device ID | K151742 |
| 510k Number | K151742 |
| Device Name: | Contour Next Control Solution |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Contact | Jennifer L. Gregory |
| Correspondent | Jennifer L. Gregory BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-29 |
| Decision Date | 2015-09-23 |
| Summary: | summary |