RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K062567 · decided 2007-02-16
Clearance details
- K-number
- K062567
- Device name
- RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
- Applicant
- Bionime Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-08-31
- Decision date
- 2007-02-16
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus Scienti recall (Z-0728-2008) | Invictus Scientific Inc | 2008-02-16 |