510(k) K163490 ยท PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
StatStrip Xpress 2 Glucose Hospital Meter System
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Jan 6, 2017 |
| Received | Dec 12, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163490
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.