510(k) K063754 ยท DHA System, Test, Human Chorionic Gonadotropin
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | Dec 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063754
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.