510(k) K161856 ยท PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
StatStrip Xpress Glucose Hospital Meter System
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Nov 15, 2016 |
| Received | Jul 6, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161856
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.