GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1— 510(k) K073648
Substantially EquivalentApex BioTechnology Corp.
FDA 510(k) clearance K073648 for GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1, Substantially Equivalent on 2008-04-10. 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
- Traditional
- 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.