510(k) K191184 ยท MJH Legionella, Spp., Elisa
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
| Applicant | Ssi Diagnostica A/S, Hilleroed, DK |
| Decision | Substantially Equivalent, Mar 5, 2020 |
| Received | May 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191184
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.