Product code DHF— Immunology

VENTANA EMA PRIMARY ANDIBODY

Classification name: D/Km-1, Antigen, Antiserum, Control
Device class: Class 1
Regulation: 21 CFR 866.5065
Advisory panel: Immunology
Total cleared: 1
First cleared: 1994-09-07
Most recent: 1994-09-07

Market context for product code DHF

FDA has cleared 1 device under product code DHF, all in 1994, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code DHF

Ventana Medical Systems, Inc.1 clearance

Recent clearances under product code DHF

K940243 — VENTANA EMA PRIMARY ANDIBODYVentana Medical Systems, Inc.·1994-09-07

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