The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Glucose.
| Device ID | K060383 |
| 510k Number | K060383 |
| Device Name: | GLUCOSE |
| Classification | Hexokinase, Glucose |
| Applicant | ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-05-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GLUCOSE 78764828 not registered Dead/Abandoned |
Glucose Media, Inc. 2005-12-01 |