510(k) K981297 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 18, 1998 |
| Received | Apr 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE /IMMULITE 1000 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.