Product code DFL— Immunology

FIAGEN FERRITIN

Classification name
Igm, Ferritin, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5550
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

Market context for product code DFL

FDA has cleared 3 devices under product code DFL between 1978 and 1988, filed by 3 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 DFL

Recent clearances under product code DFL

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