The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Ascensia Dex 2 Diabetes Care System.
| Device ID | K023584 |
| 510k Number | K023584 |
| Device Name: | ASCENSIA DEX 2 DIABETES CARE SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46515 -0070 |
| Contact | George M Tancros |
| Correspondent | George M Tancros BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46515 -0070 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-25 |
| Decision Date | 2002-11-20 |
| Summary: | summary |