NJW — Control Material, Her-2/Neu, Immunohistochemistry Class II
FDA product code NJW covers "Control Material, Her-2/Neu, Immunohistochemistry", a Class II medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NJW
- Device Class
- Class II
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Definition
Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.