510(k) K153117 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
| Applicant | Aesku Systems GmbH&Co.Kg, Wendelsheim, DE |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Oct 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153117
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.