510(k) K132391 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL
| Applicant | Siemens Helathcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 20, 2013 |
| Received | Aug 1, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K132391
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.