The following data is part of a premarket notification filed by Vivachek Laboratories, Inc. with the FDA for Vivachek Ino Smart Blood Glucose Monitoring System, Vivachek Ino Sync Blood Glucose Monitoring System, Vivachek Ino Sound Blood Glucose Monitoring System, Vivachek Ino Plus Blood Glucose Monitoring System, Vivachek Ino Sound Simple Blood Glucose Moni.
| Device ID | K173140 |
| 510k Number | K173140 |
| Device Name: | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Moni |
| 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 |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853483008243 | K173140 | 000 |
| 00853483008236 | K173140 | 000 |
| 00850042929049 | K173140 | 000 |
| 00850042929032 | K173140 | 000 |
| 00850042929025 | K173140 | 000 |
| 00850042929018 | K173140 | 000 |
| 00850042929001 | K173140 | 000 |
| 00810115892441 | K173140 | 000 |
| 00810115892359 | K173140 | 000 |