The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System.
| Device ID | K091820 |
| 510k Number | K091820 |
| Device Name: | CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Contact | Marc Henn |
| Correspondent | Marc Henn BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
| Product Code | NBW |
| Subsequent Product Code | JQP |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-18 |
| Decision Date | 2009-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00301933515013 | K091820 | 000 |