510(k) K990431 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
AIA-PACK CA 125
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Jun 3, 1999 |
| Received | Feb 11, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990431
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.