510(k) K140258 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 5, 2014 |
| Received | Feb 3, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140258
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.