TRUE METRIX GO Self Monitoring Blood Glucose System
FDA 510(k) clearance K143548 · decided 2016-04-01
Clearance details
- K-number
- K143548
- Device name
- TRUE METRIX GO Self Monitoring Blood Glucose System
- Applicant
- Trividia Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-15
- Decision date
- 2016-04-01
- Days to decision
- 473 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Owner's Booklets and Instructions for Use that are used with the following blood glucose m recall (Z-1548-2026) | Trividia Health, Inc. | 2026-03-12 |