The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Blood Sugar.
Device ID | K781783 |
510k Number | K781783 |
Device Name: | BLOOD SUGAR |
Classification | Glucose Dehydrogenase, Glucose |
Applicant | GILFORD DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LFR |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-19 |
Decision Date | 1978-12-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BLOOD SUGAR 88245273 not registered Live/Pending |
Jeffree Star Cosmetics, Inc. 2018-12-29 |