The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Glucometer Elite Test Strips.
| Device ID | K991242 |
| 510k Number | K991242 |
| Device Name: | GLUCOMETER ELITE TEST STRIPS |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-06-30 |
| Summary: | summary |