510(k) K992858 ยท LPS Urinary Homocystine (Nonquantitative) Test System
ABBOTT AXSYM HOMOCYSTEINE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Oct 25, 1999 |
| Received | Aug 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2003 | Abbott Laboratories HPD/ADD/GPRD AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA Terminated |
LPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.