DeviceClearance

Product code NJW— Hematology

Her-2, ER, PR IHControls

Classification name
Control Material, Her-2/Neu, Immunohistochemistry
Device class
Class 2
Regulation
21 CFR 864.1860
Advisory panel
Hematology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.”

— U.S. Food and Drug Administration, device classification record for product code NJW under 21 CFR 864.1860, via openFDA

Market context for product code NJW

FDA has cleared 2 devices under product code NJW between 2003 and 2022, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NJW

Recent clearances under product code NJW

Data sourced from openFDA. This site is unofficial and independent of the FDA.