DeviceClearance

Product code DFC— Immunology

LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

Classification name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5600
Advisory panel
Immunology
Total cleared
43
First cleared
Most recent

Market context for product code DFC

FDA has cleared 43 devices under product code DFC between 1977 and 2026, filed by 28 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 DFC

Recent clearances under product code DFC

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