The following data is part of a premarket notification filed by Bestgen Biotech Corp. with the FDA for Ap-3000 Blood Glucose Monitoring System, Major Glucose Control Solution.
| Device ID | K103230 |
| 510k Number | K103230 |
| Device Name: | AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION |
| Classification | Glucose Oxidase, Glucose |
| Applicant | BESTGEN BIOTECH CORP. 7F, NO 186, JIAN-YI ROAD Jung-he, Taipei County, TW 235 |
| Contact | Steven Shen |
| Correspondent | Steven Shen BESTGEN BIOTECH CORP. 7F, NO 186, JIAN-YI ROAD Jung-he, Taipei County, TW 235 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2012-04-24 |
| Summary: | summary |