DeviceClearance

Contour Next Control Solution— 510(k) K151742

Substantially Equivalent

Bayer Healthcare

FDA 510(k) clearance K151742 for Contour Next Control Solution, Substantially Equivalent on 2015-09-23. Applicant: Bayer Healthcare.

Clearance details

Applicant
Bayer Healthcare
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mishawaka, IN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.