The following data is part of a premarket notification filed by Bestgen Biotech Corp. with the FDA for Ap-1000 Blood Glucose Monitoring System, Model Ap-1000, Major Glucose Control Solution.
| Device ID | K100437 |
| 510k Number | K100437 |
| Device Name: | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BESTGEN BIOTECH CORP. 7F, NO.186, JIAN 1ST RD., Jhonghe City, Taipei County, TW 23511 |
| Contact | Steven Shen |
| Correspondent | Steven Shen BESTGEN BIOTECH CORP. 7F, NO.186, JIAN 1ST RD., Jhonghe City, Taipei County, TW 23511 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2012-01-12 |
| Summary: | summary |