AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III— 510(k) K113098
Substantially EquivalentApex BioTechnology Corp.
FDA 510(k) clearance K113098 for AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III, Substantially Equivalent on 2012-01-17. Applicant: Apex BioTechnology Corp.. Device class: 2.
Clearance details
- Applicant
- Apex BioTechnology Corp.
- Product code
- Product code NBW
- 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
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More clearances from Apex BioTechnology Corp.
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- 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 NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
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.