Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
FDA 510(k) clearance K150396 · decided 2015-10-14
Clearance details
- K-number
- K150396
- Device name
- Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
- Applicant
- Apex BioTechnology Corp.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-18
- Decision date
- 2015-10-14
- Days to decision
- 238 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hsinchu, CN
- Third-party review
- No
- Expedited review
- No
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| VivaChek Link Plus Blood Glucose Monitoring System (K233058) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 |
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Recalls involving this device
No recalls on record reference this clearance.