Panels › Hematology › Product code MXZ · Class 2
Immunohistochemistry Assay, Antibody, Progesterone Receptor
Regulation 864.1860
0510(k)s in 12 months (13 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in MXZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Leica Biosystems Newcastle, Limited | 3 | 0 |
| Dako North America, Inc. | 2 | 0 |
| Ventana Medical Systems, Inc. | 1 | 1 |
| Zymed Laboratories Inc. | 0 | 2 |
| Biogenex Laboratories | 1 | 0 |
| Dako Corp. | 1 | 0 |
| Dako Denmark A/S | 1 | 0 |
| Dakocytomation California, Inc. | 1 | 0 |
| Lab Vision Corp. | 1 | 0 |
| Ventana Medical Sytems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2018 | Ventana Medical Systems Inc CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
MXZ | K103818 |
| Oct 9, 2004 | Zymed Laboratories Inc. Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient. Terminated |
MXZ | None listed |
| Oct 9, 2004 | Zymed Laboratories Inc. Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient. Terminated |
MXZ | None listed |
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