DeviceClearance

Product code DGK— Immunology

FIAX IGG TEST KIT

Classification name
Igg, Fitc, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

Market context for product code DGK

FDA has cleared 2 devices under product code DGK, all in 1983, 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.

Top applicants under product code DGK

Recent clearances under product code DGK

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