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 |