510(k) K071603 ยท DHX System, Test, Carcinoembryonic Antigen
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jun 25, 2008 |
| Received | Jun 12, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071603
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.