510(k) K023397 ยท CGN Acid, Folic, Radioimmunoassay
ABBOTT ARCHITECT FOLATE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 16, 2002 |
| Received | Oct 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and 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 ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of 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 ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent 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 ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12- Terminated |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.