510(k) K963926 ยท MOI System, Test, Immunological, Antigen, Tumor
AXSYM CA 15-3
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 15, 1997 |
| Received | Sep 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963926
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2007 | Abbott Laboratories AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
MOI | None listed |
| Jul 18, 2006 | Abbott Laboratories MPG CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (hu Terminated |
MOI | None listed |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbot Terminated |
MOI | None listed |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u Terminated |
MOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.