510(k) K140100 ยท NBW System, Test, Blood Glucose, Over The Counter
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
| Applicant | Nipro Diagnostics, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Aug 1, 2014 |
| Received | Jan 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2026 | Trividia Health, Inc. Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item:
Walgreens TRUE METRIX Kit/RE4001-01,
Leader TRUE METRIX Kit/RE4002-01,
L Open, Classified |
NBW | None listed |
| Mar 12, 2026 | Trividia Health, Inc. Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item:
TRUE METRIX PRO Meter Only/RE4H01P-40,
TRUE METRIX PRO Starter Kit/RE4H Open, Classified |
NBW | None listed |
| Oct 30, 2025 | Trividia Health, Inc. Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01. Open, Classified |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.