510(k) K200788 ยท PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Assure Titanium Blood Glucose Monitoring System
| Applicant | Arkray, Inc., Kamigyo-Ku, JP |
| Decision | Substantially Equivalent, May 23, 2022 |
| Received | Mar 26, 2020 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K200788
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.