The following data is part of a premarket notification filed by Labstyle Innovations Ltd. with the FDA for Dario Blood Glucose Monitoring System.
| Device ID | K150817 |
| 510k Number | K150817 |
| Device Name: | Dario Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LabStyle Innovations Ltd. 3521 HATWYNN RD. Charlotte, NC 28269 |
| Contact | Tracey Wielinski |
| Correspondent | Tracey Wielinski LabStyle Innovations Ltd. 3521 HATWYNN RD. Charlotte, NC 28269 |
| 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 | 2015-03-27 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850065006253 | K150817 | 000 |
| 00850065006000 | K150817 | 000 |
| 00850065006406 | K150817 | 000 |
| 00850065006451 | K150817 | 000 |
| 00850065006444 | K150817 | 000 |
| 00850065006505 | K150817 | 000 |
| 00850065006574 | K150817 | 000 |
| 00850065006567 | K150817 | 000 |
| 00850065006659 | K150817 | 000 |
| 00850065006017 | K150817 | 000 |
| 00850065006024 | K150817 | 000 |
| 00850065006246 | K150817 | 000 |
| 00850065006215 | K150817 | 000 |
| 00850065006192 | K150817 | 000 |
| 00850065006185 | K150817 | 000 |
| 00850065006178 | K150817 | 000 |
| 00850065006161 | K150817 | 000 |
| 00850065006109 | K150817 | 000 |
| 00850065006048 | K150817 | 000 |
| 00850065006758 | K150817 | 000 |