DeviceClearance

Product code DHB— Immunology

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

Classification name
System, Test, Radioallergosorbent (Rast) Immunological
Device class
Class 2
Regulation
21 CFR 866.5750
Advisory panel
Immunology
Total cleared
268
First cleared
Most recent

Market context for product code DHB

FDA has cleared 268 devices under product code DHB between 1977 and 2026, filed by 41 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 DHB

Recent clearances under product code DHB

1–100 of 268

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