510(k) K140267 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 10, 2014 |
| Received | Feb 3, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140267
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.