DeviceClearance

Product code DHX— Immunology

ABBOTT ARCHITECT CEA

Classification name
System, Test, Carcinoembryonic Antigen
Device class
Class 2
Regulation
21 CFR 866.6010
Advisory panel
Immunology
Total cleared
28
First cleared
Most recent

Market context for product code DHX

FDA has cleared 28 devices under product code DHX between 1980 and 2023, filed by 24 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 DHX

Recent clearances under product code DHX

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