510(k) K110571 ยท NBW System, Test, Blood Glucose, Over The Counter
TELCARE BLOOD GLUCOSE MONITORING SYSTEM, TEST STRIPS, CONTROL SOLUTIONS, TELSERVE-HOME USE, TELSERVE-PROFESSIONAL USE
| Applicant | Telcare, Inc., Bethesda MD, US |
| Decision | Substantially Equivalent, Jul 28, 2011 |
| Received | Mar 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2025 | Telcare, LLC Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009; Open, Classified |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.