510(k) K111268 ยท LFR Glucose Dehydrogenase, Glucose
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Bayer Healthcare, Mishawaka IN, US |
| Decision | Substantially Equivalent, Mar 6, 2012 |
| Received | May 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2015 | Bayer Healthcare, LLC Contour Next Control Solution for Contour Next Blood Glucose Test System.
Liquid quality control solution. Plastic bottle, 2.5mL.
Indicated for use with fresh fingertip capillary whole blood samples Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.