510(k) K940682 ยท LGI Fluorescence Polarization Immunoassay, Carbamazepine
AXSYM(TM) QUINIDINE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jun 21, 1994 |
| Received | Feb 10, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940682
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2007 | Abbott Diagnostic International, Ltd. AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01 Terminated |
LGI | None listed |
| Aug 22, 2007 | Abbott Diagnostic International, Ltd. AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing quinidine prepared in human serum to yield the differ Terminated |
LGI | None listed |
| Aug 22, 2007 | Abbott Diagnostic International, Ltd. XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).-Product List Number-9506-01 Terminated |
LGI | None listed |
| Aug 22, 2007 | Abbott Diagnostic International, Ltd. XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number Terminated |
LGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.