510(k) K983391 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
IMMULITE 2000 OM-MA MODEL L2KOP2
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 15, 1998 |
| Received | Sep 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983391
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125) Terminated |
LTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.