FDA Product Code NJW: Control Material, Her-2/neu, Immunohistochemistry
Accessory To Immunohistochemistry Assays For Her2-neu. Control Material Intended For Laboratory Use To Control Her2-neu Immunohistochemistry Assays.
Leading manufacturers include Boston Cell Standards, Inc..
2
Total
2
Cleared
231d
Avg days
2003
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Control Material, Her-2/neu, Immunohistochemistry Devices (Product Code NJW)
2 devices
About Product Code NJW - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code NJW since 2003, with 2 receiving FDA clearance (average review time: 231 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
NJW devices are reviewed by the Pathology panel. Browse all Pathology devices →