510(k) K150052 ยท NBW System, Test, Blood Glucose, Over The Counter
TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
| Applicant | Nipro Diagnostics, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Mar 26, 2015 |
| Received | Jan 12, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150052
| 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 AIR Kit/REA4001-01,
Leader TRUE METRIX AIR Kit/REA4 Open, Classified |
NBW | None listed |
| Apr 20, 2020 | Trividia Health, Inc. TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or for Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.