510(k) K162822 ยท PDJ Hemoglobin A1c Test System
ADAMS A1c HA-8180V, CALIBRATOR 80
| Applicant | Arkray Factory, Inc., Koka-Shi, JP |
| Decision | Substantially Equivalent, Jun 29, 2017 |
| Received | Oct 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162822
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.