510(k) K161533 ยท LCP Assay, Glycosylated Hemoglobin
A1C EZ Glycohemoglobin Analysis System
| Applicant | Biohermes Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Jun 16, 2017 |
| Received | Jun 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161533
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.