The following data is part of a premarket notification filed by Bayer Group Diagnostics with the FDA for Glucometer Elite Diabetes Care System (modified).
| Device ID | K020208 |
| 510k Number | K020208 |
| Device Name: | GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BAYER GROUP DIAGNOSTICS 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46515 -0070 |
| Contact | George M Tancos |
| Correspondent | George M Tancos BAYER GROUP DIAGNOSTICS 1884 MILES AVE. P.O. BOX 70 Elkhart, IN 46515 -0070 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-22 |
| Decision Date | 2002-04-29 |
| Summary: | summary |