510(k) K984108 ยท LIG Radioassay, Intrinsic Factor Blocking Antibody
ABBOTT ARCHITECT B12
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Feb 3, 1999 |
| Received | Nov 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2006 | Abbott Laboratories MPG ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and Terminated |
LIG | None listed |
| Jan 26, 2005 | Abbott Laboratories, Inc B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The A Terminated |
LID | None listed |
| Sep 14, 2004 | Abbott Laboratories HPD/ADD/GPRD ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany Terminated |
LIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.