510(k) K964407 ยท MOI System, Test, Immunological, Antigen, Tumor
IMX CA 15-3
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 10, 1997 |
| Received | Nov 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 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 |
| Mar 26, 2003 | Abbott Laboratories HPD/ADD IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains one 4-mL bottle of Mode 1 Calibrator along with other reagents; Abbott Laboratories, Abbott Park, IL Terminated |
MOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.