DeviceClearance

Product code DBE— Immunology

AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY

Classification name
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Device class
Class 2
Regulation
21 CFR 866.5120
Advisory panel
Immunology
Total cleared
6
First cleared
Most recent

Market context for product code DBE

FDA has cleared 6 devices under product code DBE between 1976 and 1981, 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 DBE

Recent clearances under product code DBE

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