Panels › Immunology › Product code DGC · Class 2
Ige, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (114 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in DGC
| Company | 510(k)s | Recalls |
|---|---|---|
| Pharmacia, Inc. | 16 | 0 |
| Ventrex Laboratories, Inc. | 12 | 0 |
| Kallestad Laboratories, Inc. | 8 | 0 |
| Diagnostic Products Corp. | 6 | 0 |
| Hybritech, Inc. | 4 | 0 |
| Allergenetics | 3 | 0 |
| Mast Immunosystems | 3 | 0 |
| Quidel Corp. | 3 | 0 |
| 3M Company | 2 | 0 |
| Abbott Laboratories | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK IGE II; Part Number: 025295
Assay, Allergy Terminated |
DGC | K972697 |
| Oct 6, 2016 | Randox Laboratories Ltd. IgE Calibrator Series Terminated |
DGC | K010855 |
| May 26, 2009 | Siemens Medical Solutions Diagnostics Immulite 2000 and Immulite 2500 digital Fluidics PC Board,
Part Number 450116-0002.
Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing. Terminated |
DGC | K033234 K970227 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.