DeviceClearance

Product code JZG— Immunology

BETA-2 MICROGLOBULIN EIA

Classification name
System, Test, Beta-2-Microglobulin Immunological
Device class
Class 2
Regulation
21 CFR 866.5630
Advisory panel
Immunology
Total cleared
53
First cleared
Most recent

Market context for product code JZG

FDA has cleared 53 devices under product code JZG between 1984 and 2016, filed by 32 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

last 15 years

Top applicants under product code JZG

Recent clearances under product code JZG

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