510(k) K170147 ยท LCP Assay, Glycosylated Hemoglobin
Lucica Glycated Albumin-L
| Applicant | Asahi Kasei Pharma Corporation, Tokyo, JP |
| Decision | Substantially Equivalent, Oct 12, 2017 |
| Received | Jan 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170147
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.