Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System
FDA 510(k) clearance K141292 · decided 2015-06-09
Clearance details
- K-number
- K141292
- Device name
- Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System
- Applicant
- Bionime Coporation
- Decision
- Substantially Equivalent
- Date received
- 2014-05-19
- Decision date
- 2015-06-09
- Days to decision
- 386 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Juan Capistrano, CA, US
- 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.