The following data is part of a premarket notification filed by Vivachek Laboratories, Inc. with the FDA for Vivachek Ino Blood Glucose Monitoring System.
| Device ID | K160179 |
| 510k Number | K160179 |
| Device Name: | VivaChek Ino Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | VIVACHEK LABORATORIES, INC. 913 N MARKET STREET SUITE 200 Wilmington, DE 19081 |
| Contact | Julie Zhou |
| Correspondent | Julie Zhou VIVACHEK LABORATORIES, INC. 913 N MARKET STREET SUITE 200 Wilmington, DE 19081 |
| 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 | 2016-01-27 |
| Decision Date | 2017-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853483008151 | K160179 | 000 |
| 00853483008052 | K160179 | 000 |
| 00853483008014 | K160179 | 000 |
| 00853483008007 | K160179 | 000 |
| 00853483008199 | K160179 | 000 |
| 00853483008182 | K160179 | 000 |
| 00853483008175 | K160179 | 000 |
| 00853483008076 | K160179 | 000 |