510(k) K121084 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 9, 2012 |
| Received | Apr 10, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K121084
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.