510(k) K121576 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
IMMULITE 2000 ANTI-CCP IGG ASSAY
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Apr 4, 2013 |
| Received | May 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121576
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.