The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Glucometer Dex Test Sensor.
| Device ID | K012205 |
| 510k Number | K012205 |
| Device Name: | GLUCOMETER DEX TEST SENSOR |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
| Contact | George M Tancos |
| Correspondent | George M Tancos BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-09-12 |
| Summary: | summary |