The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Glucoleader Value.
| Device ID | K023279 |
| 510k Number | K023279 |
| Device Name: | GLUCOLEADER VALUE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | HMD BIOMEDICAL, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman HMD BIOMEDICAL, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-01 |
| Decision Date | 2003-08-04 |