510(k) K143373 · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
| Applicant | Siemens Healthcare Diagnostics, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Feb 26, 2015 |
| Received | Nov 25, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K143373
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.