Panels › Hematology › Product code MYA · Class 2
Immunohistochemistry Antibody Assay, Estrogen Receptor
Regulation 864.1860
0510(k)s in 12 months (12 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in MYA
| Company | 510(k)s | Recalls |
|---|---|---|
| Ventana Medical Systems, Inc. | 1 | 3 |
| Dako North America, Inc. | 2 | 0 |
| Leica Biosystems Newcastle, Limited | 2 | 0 |
| Biogenex Laboratories | 1 | 0 |
| Chroma Vision Medical Systems, Inc. | 1 | 0 |
| Dako Corp. | 1 | 0 |
| Dako Denmark A/S | 1 | 0 |
| Lab Vision Corp. | 1 | 0 |
| Ventana, Inc. | 1 | 0 |
| Vision Biosystems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2018 | Ventana Medical Systems Inc CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
MYA | K110215 |
| Jul 1, 2011 | Ventana Medical Systems Inc iView DAB Detection Kit, Part number: 760-091
(05266157001)
This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect bioti Terminated |
MYA | K984567 K990618 |
| Jul 1, 2011 | Ventana Medical Systems Inc ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001)
This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an Terminated |
MYA | K984567 K990618 |
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