The following data is part of a premarket notification filed by Bayer Healthcare, Llc with the FDA for Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (high, Normal, Low).
| Device ID | K110587 |
| 510k Number | K110587 |
| Device Name: | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | BAYER HEALTHCARE, LLC 555 WHITE PLAINS ROAD Tarrytown, NY 10591 |
| Contact | Chuck Ryan |
| Correspondent | Chuck Ryan BAYER HEALTHCARE, LLC 555 WHITE PLAINS ROAD Tarrytown, NY 10591 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-01 |
| Decision Date | 2012-03-28 |
| Summary: | summary |