510(k) K143504 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 14, 2015 |
| Received | Dec 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143504
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.