The following data is part of a premarket notification filed by Labstyle Innovation, Ltd. with the FDA for Dario Lc Blood Glucose Monitoring System.
| Device ID | K172723 |
| 510k Number | K172723 |
| Device Name: | Dario LC Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LabStyle Innovation, Ltd. 9 Halamish Street, North Industrial Park Caesarea, IL 3890000 |
| Contact | Erez Raphael |
| Correspondent | Tracey Wielinski Qualtra Consulting 5 Casie Lane Pepperell, MA 01463 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-11 |
| Decision Date | 2018-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850065006154 | K172723 | 000 |
| 00850065006390 | K172723 | 000 |
| 00850065006741 | K172723 | 000 |