510(k) K972232 ยท CGN Acid, Folic, Radioimmunoassay
ABBOTT AXSYM FOLATE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 24, 1997 |
| Received | Jun 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2009 | Abbott Laboratories AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on t Terminated |
CGN | None listed |
| Jul 11, 2007 | Abbott Laboratories AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
CGN | None listed |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | None listed |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | None listed |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD AxSYM Folate Medium Control Pack , list 3C81-11, the pack contains 8 - 1 mL vials of Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | None listed |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each level), Low Control L 2.5 ng/mL and High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.