510(k) K161522 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
LIAISON EBV IgM Serum Control Set
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Jun 30, 2016 |
| Received | Jun 2, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161522
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.