510(k) K121895 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS HSV-2 IGG IMMUNOASSAY
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 24, 2012 |
| Received | Jun 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121895
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.