510(k) K181915 ยท LCP Assay, Glycosylated Hemoglobin
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
| Applicant | Ixensor Co, Ltd., Taipei City, TW |
| Decision | Substantially Equivalent, Apr 12, 2019 |
| Received | Jul 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181915
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.