510(k) K083339 ยท CIC Cresolphthalein Complexone, Calcium
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 9, 2009 |
| Received | Nov 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083339
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.