510(k) K980240 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
ELECSYS CA 125II ON THE ELECSYS 1010
| Applicant | Boehringer Mannheim Corp., Pleasanton CA, US |
| Decision | Substantially Equivalent, Mar 25, 1998 |
| Received | Jan 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980240
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.