510(k) K031343 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
TPSA FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 15, 2003 |
| Received | Apr 29, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031343
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.