The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour (r) Next Blood Glucose Monitoring System.
| Device ID | K111268 |
| 510k Number | K111268 |
| Device Name: | CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Contact | Weiping Zhong |
| Correspondent | Weiping Zhong BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-04 |
| Decision Date | 2012-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40301939628012 | K111268 | 000 |
| 40301937252011 | K111268 | 000 |
| 40301939647518 | K111268 | 000 |
| 40301935534515 | K111268 | 000 |
| 40301937553019 | K111268 | 000 |