Panels › Clinical Toxicology › Product code LGI · Class 2
Fluorescence Polarization Immunoassay, Carbamazepine
Regulation 862.3645
0510(k)s in 12 months (3 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in LGI
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Diagnostic International, Ltd. | 0 | 4 |
| Abbott Laboratories | 1 | 0 |
| Innotron of Oregon, Inc. | 1 | 0 |
| Sigma Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K940682 |
| 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 | K940682 |
| 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 | K940682 |
| 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 | K940682 |
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