510(k) K943691 ยท CGN Acid, Folic, Radioimmunoassay
IMX FOLATE
| Applicant | Abbott Mfg., Inc., Abbott Park IL, US |
| Decision | Substantially Equivalent, Mar 23, 1995 |
| Received | Jul 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943691
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate 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 IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx Folate Mode 1 Calibrator 3.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | None listed |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
CGN | None listed |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 600 Terminated |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.