DeviceClearance

Product code DFH— Immunology

N Latex FLC kappa, N Latex FLC lambda

Classification name
Kappa, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5550
Advisory panel
Immunology
Total cleared
63
First cleared
Most recent

Market context for product code DFH

FDA has cleared 63 devices under product code DFH between 1978 and 2025, filed by 23 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 DFH

Recent clearances under product code DFH

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