Product code CZX— Immunology

ANTISERUM TO HUMAN HEMOPEXIN

Classification name
Hemopexin, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5490
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

Market context for product code CZX

FDA has cleared 3 devices under product code CZX between 1978 and 1980, filed by 3 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 CZX

Recent clearances under product code CZX

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