510(k) K140541 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 1, 2014 |
| Received | Mar 4, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140541
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.