GAL-1A BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K113208
Substantially EquivalentApex BioTechnology Corp.
FDA 510(k) clearance K113208 for GAL-1A BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-01-26. Applicant: Apex BioTechnology Corp.. Device class: 2.
Clearance details
- Applicant
- Apex BioTechnology 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
- Special
- Location
- Hsinchu, TW
Recent devices under product code CGA
view allMore clearances from Apex BioTechnology Corp.
view all- K242209 — UASure II Blood Uric Acid Monitoring System
- K222234 — GlucoSure ADVANCE Link Blood Glucose Monitoring System
- K220421 — BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
- K212140 — GlucoSure Link Blood Glucose Monitoring System
- K202534 — MTM301 Blood Glucose and Ketone 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.