The following data is part of a premarket notification filed by Bestgen Biotech Corp. with the FDA for Ap-1000 Blood Glucose Monitoring System.
| Device ID | K090389 |
| 510k Number | K090389 |
| Device Name: | AP-1000 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | BESTGEN BIOTECH CORP. NO. 58 FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min BESTGEN BIOTECH CORP. NO. 58 FU CHIUN STREET Hsin Chu City, TW 30067 |
| 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 | 2009-02-17 |
| Decision Date | 2009-07-14 |
| Summary: | summary |