510(k) K964098 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 31, 1997 |
| Received | Oct 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964098
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.