510(k) K170623 ยท LCP Assay, Glycosylated Hemoglobin
ACE Hemoglobin A1c (HbA1c) Reagent
| Applicant | Alfa Wassermann Diagnostic Technologies, LLC, West Caldwell NJ, US |
| Decision | Substantially Equivalent, Feb 27, 2018 |
| Received | Mar 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170623
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.