The following data is part of a premarket notification filed by Us Diagnostics, Inc. with the FDA for Easygluco, Model Igm-0002 G2.
| Device ID | K061431 |
| 510k Number | K061431 |
| Device Name: | EASYGLUCO, MODEL IGM-0002 G2 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | US DIAGNOSTICS, INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301 |
| Contact | Edward Letko |
| Correspondent | Edward Letko US DIAGNOSTICS, INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-24 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885502016038 | K061431 | 000 |
| 00885502015031 | K061431 | 000 |
| 00885502004035 | K061431 | 000 |
| 00885502001034 | K061431 | 000 |
| 00885502000037 | K061431 | 000 |