The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Glucometer Dex Diabetes Care System.
| Device ID | K963500 |
| 510k Number | K963500 |
| Device Name: | GLUCOMETER DEX DIABETES CARE SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
| Contact | Rosanne M Savol, R.a.c. |
| Correspondent | Rosanne M Savol, R.a.c. BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1997-01-21 |
| Summary: | summary |