The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Glucometer Elite Xl Blood Glucose Meter, Glucometer Elite Blood Glucose Test Systems.
| Device ID | K990649 |
| 510k Number | K990649 |
| Device Name: | GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS |
| 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 | 1999-03-01 |
| Decision Date | 1999-07-09 |
| Summary: | summary |