DeviceClearance

Product code NTH— Immunology

ARIOL HER-2/NEU FISH

Classification name
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Device class
Class 2
Regulation
21 CFR 866.4700
Advisory panel
Immunology
Total cleared
8
First cleared
Most recent

Market context for product code NTH

FDA has cleared 8 devices under product code NTH between 2004 and 2014, filed by 6 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 NTH

Recent clearances under product code NTH

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