510(k) K192369 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, Oct 29, 2019 |
| Received | Aug 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192369
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.