The following data is part of a premarket notification filed by Us Diagnostics, Inc. with the FDA for G5 Infinity Blodo Glucose Monitoring System With Model Igm, 0024a.
| Device ID | K082201 |
| 510k Number | K082201 |
| Device Name: | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A |
| 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 J Johnson |
| Correspondent | Jonathan J Johnson US DIAGNOSTICS, INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-05 |
| Decision Date | 2009-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885502016007 | K082201 | 000 |
| 00885502015000 | K082201 | 000 |
| 00885502004004 | K082201 | 000 |
| 00885502001003 | K082201 | 000 |
| 00885502000006 | K082201 | 000 |