The following data is part of a premarket notification filed by Delbio Incorporation with the FDA for Diatrue Plus Blood Glucose Monitoring System; Diatrue Plus Blood Glucose Test Strip; Diatrue Glucose Control Solution.
| Device ID | K103329 |
| 510k Number | K103329 |
| Device Name: | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | DELBIO INCORPORATION 252, SHANGYING ROAD GUISHAN INDUSTRIAL ZONE Taoyuan County, TW 33341 |
| Contact | Nicky Pan |
| Correspondent | Nicky Pan DELBIO INCORPORATION 252, SHANGYING ROAD GUISHAN INDUSTRIAL ZONE Taoyuan County, TW 33341 |
| 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 | 2010-11-12 |
| Decision Date | 2012-03-13 |