DeviceClearance

Product code DGR— Immunology

ICS NORMAL CONTROL SERUM

Classification name
Whole Human Serum, Antigen, Antiserum, Control
Device class
Class 1
Regulation
21 CFR 866.5700
Advisory panel
Immunology
Total cleared
5
First cleared
Most recent

Market context for product code DGR

FDA has cleared 5 devices under product code DGR between 1978 and 1996, filed by 5 applicant companies. 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.

Clearances per year

Top applicants under product code DGR

Recent clearances under product code DGR

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