510(k) K172461 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
| Applicant | Aesku.Diagnostics GmbH & Co. KG, Wendelsheim, DE |
| Decision | Substantially Equivalent, Mar 23, 2018 |
| Received | Aug 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172461
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.