AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION— 510(k) K103230
Substantially EquivalentBestgen Biotech Corp.
FDA 510(k) clearance K103230 for AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION, Substantially Equivalent on 2012-04-24. Applicant: Bestgen Biotech Corp.. Device class: 2.
Clearance details
- Applicant
- Bestgen Biotech Corp.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jung-He, Taipei County, TW
Recent devices under product code CGA
view allMore clearances from Bestgen Biotech Corp.
view all- K103116 — AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
- K103044 — AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
- K100437 — AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
- K090389 — AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
- K072274 — MAJOR III BLOOD GLUCOSE MONITORING SYSTEM
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.