The following data is part of a premarket notification filed by Standard Diagnostics, Inc. with the FDA for Smartlink Gold Blood Glucose Monitoring System.
| Device ID | K100398 |
| 510k Number | K100398 |
| Device Name: | SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | STANDARD DIAGNOSTICS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 -1734 |
| Contact | Susan Goldstein-falk |
| Correspondent | Susan Goldstein-falk STANDARD DIAGNOSTICS, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 -1734 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887473000160 | K100398 | 000 |
| 00887473000139 | K100398 | 000 |
| 0887473000115 | K100398 | 000 |
| 00887473000108 | K100398 | 000 |
| 00887473000016 | K100398 | 000 |
| 00887473000009 | K100398 | 000 |