The following data is part of a premarket notification filed by Us Diagnostics, Inc. with the FDA for Easygluco Plus Blood Glucose Monitoring System.
| Device ID | K110435 |
| 510k Number | K110435 |
| Device Name: | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | US DIAGNOSTICS, INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301 |
| Contact | Jonathan Johnson |
| Correspondent | Jonathan Johnson US DIAGNOSTICS, INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-15 |
| Decision Date | 2011-09-21 |
| Summary: | summary |