510(k) K142811 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 29, 2014 |
| Received | Sep 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142811
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.