The following data is part of a premarket notification filed by Hmd Biomedical, Inc. with the FDA for Glucoleader Enhance Self-monitoring Of Blood Glucose System.
| Device ID | K032985 |
| 510k Number | K032985 |
| Device Name: | GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-24 |
| Decision Date | 2003-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711200722864 | K032985 | 000 |
| 04711200721898 | K032985 | 000 |
| 04711200720068 | K032985 | 000 |
| 04711200720570 | K032985 | 000 |
| 04711200721249 | K032985 | 000 |
| 04711200721744 | K032985 | 000 |
| 04711200720334 | K032985 | 000 |
| 04711200722840 | K032985 | 000 |
| 04711200720617 | K032985 | 000 |
| 04711200721843 | K032985 | 000 |