The following data is part of a premarket notification filed by Delbio Incorporation with the FDA for Diatrue Plus Blood Glucose Monitoring System.
| Device ID | K130244 |
| 510k Number | K130244 |
| Device Name: | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | DELBIO INCORPORATION 3F,6F, 7F No.252, Shangying Road, Guishan Industrial Zone Taoyuan County, TW 33341 |
| Contact | Nicky Pan |
| Correspondent | Nicky Pan DELBIO INCORPORATION 3F,6F, 7F No.252, Shangying Road, Guishan Industrial Zone Taoyuan County, TW 33341 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-31 |
| Decision Date | 2013-08-23 |