510(k) K022288 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 17, 2002 |
| Received | Jul 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022288
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.