510(k) K964020 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
AXSYM CA 125
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 4, 1997 |
| Received | Oct 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2007 | Abbott Laboratories AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | None listed |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | None listed |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD CA 125 Calibrators, list 9C22-01; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | None listed |
| Jan 10, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM CA 125 Master Calibrators, list 3B41-30; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
LTK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.