510(k) K150132 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
| Applicant | Siemens Healthcare Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 13, 2015 |
| Received | Jan 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150132
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.