TRUE METRIX GO Self Monitoring Blood Glucose System— 510(k) K143548
Substantially EquivalentTrividia Health, Inc.
FDA 510(k) clearance K143548 for TRUE METRIX GO Self Monitoring Blood Glucose System, Substantially Equivalent on 2016-04-01. Applicant: Trividia Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Trividia Health, Inc.
- 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
- Fort Lauderdale, FL, US
Recent devices under product code NBW
view all- K260738 — Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System
- K261293 — EASYMAX Voice Blood Glucose Monitoring System
- K260687 — VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System +1 more
- K260689 — CVS Advanced PLUS Blood Glucose Monitoring System
- K260545 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System +2 more
More clearances from Trividia Health, Inc.
view allAdverse 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 →
Recalls naming K143548
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143548.
Data sourced from openFDA. This site is unofficial and independent of the FDA.