510(k) K813218 ยท LEH Radioimmunoassay, Vancomycin
TDX VANCOMYCIN
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 8, 1981 |
| Received | Nov 9, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813218
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
LGQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.