The following data is part of a premarket notification filed by Biocare Corporation with the FDA for Diavue Prudential Blood Glucose Monitoring System.
| Device ID | K122307 |
| 510k Number | K122307 |
| Device Name: | DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BIOCARE CORPORATION 4F, NO.12, LANE 5, SEC. 2 NASHAN RD LUJIHU TOWNSHIP Taoyuan County, TW 33852 |
| Contact | Shuchi Chang |
| Correspondent | Shuchi Chang BIOCARE CORPORATION 4F, NO.12, LANE 5, SEC. 2 NASHAN RD LUJIHU TOWNSHIP Taoyuan County, TW 33852 |
| 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 | 2012-08-01 |
| Decision Date | 2013-04-05 |
| Summary: | summary |