DeviceClearance

Product code DBM— Immunology

AFT SYSTEM

Classification name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device class
Class 2
Regulation
21 CFR 866.5090
Advisory panel
Immunology
Total cleared
27
First cleared
Most recent

Market context for product code DBM

FDA has cleared 27 devices under product code DBM between 1976 and 2018, 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 DBM

Recent clearances under product code DBM

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