510(k) K191085 ยท LKO Anti-Rnp Antibody, Antigen And Control
Maverick RNP Assay and Maverick Diagnostic System
| Applicant | Genalyte, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 25, 2019 |
| Received | Apr 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191085
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.