510(k) K071597 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jun 4, 2008 |
| Received | Jun 12, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071597
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.