The following data is part of a premarket notification filed by Delbio Incorporation with the FDA for Diacheck Blood Glucose Monitoring System Model: Premium.
| Device ID | K100806 |
| 510k Number | K100806 |
| Device Name: | DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | DELBIO INCORPORATION 3F, NO. 252, SHANGYING ROAD GUISHAN INDUSTRIAL ZONE Taoyuan County, TW 33341 |
| Contact | Nicky Pan |
| Correspondent | Nicky Pan DELBIO INCORPORATION 3F, NO. 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 | 2010-03-22 |
| Decision Date | 2011-09-16 |