510(k) K972162 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
ELECSYS CA 125 II
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 18, 1998 |
| Received | Jun 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972162
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.