510(k) K003963 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
DIMENSION PSA FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 28, 2001 |
| Received | Dec 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003963
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.