DeviceClearance

Product code CZN— Immunology

FIAX IGA TEST KIT

Classification name
Iga, Fitc, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
7
First cleared
Most recent

Market context for product code CZN

FDA has cleared 7 devices under product code CZN between 1983 and 1989, 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 CZN

Recent clearances under product code CZN

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