Panels › Immunology › Product code DFC · Class 2
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Regulation 866.5600
1510(k)s in 12 months (43 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in DFC
| Company | 510(k)s | Recalls |
|---|---|---|
| Wako Chemicals USA, Inc. | 9 | 1 |
| DiaSorin, Inc. | 3 | 1 |
| Roche Diagnostics | 4 | 0 |
| Kamiya Biomedical Co. | 2 | 1 |
| Abbott Laboratories | 1 | 1 |
| Diazyme Laboratories, Inc. | 2 | 0 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 2 | 0 |
| Randox Laboratories, Limited | 0 | 2 |
| Axis Biochemicals, Asa | 1 | 0 |
| Beckman Coulter, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2025 | Randox Laboratories, Limited Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers.
Catalog Number: LP2757 Open, Classified |
DFC | K011568 |
| Jan 23, 2025 | Randox Laboratories, Limited Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers.
Catalog Number: LP3403 Open, Classified |
DFC | K011568 |
| May 16, 2018 | Abbott Laboratories, Inc Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of
apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine
with apolipoprotein B in the sa Terminated |
DFC | K983281 |
| Apr 6, 2012 | Wako Chemicals USA, Inc. Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo Terminated |
DFC | K981446 |
| Mar 18, 2005 | Diasorin Inc. Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent K Terminated |
DFC | K982708 |
| Jul 20, 2004 | Kamiya Biomedical Company K-Assay Lp(a) Control Terminated |
DFC | K023853 |
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