DeviceClearance

Product code SFC— Immunology

APO-Easy Genotyping kit

Classification name
Neurologic Disease Risk Assessment Molecular Test
Device class
Class 2
Regulation
21 CFR 866.5850
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information.”

— U.S. Food and Drug Administration, device classification record for product code SFC under 21 CFR 866.5850, via openFDA

Market context for product code SFC

FDA has cleared 1 device under product code SFC, all in 2025, filed by 1 applicant company. 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.

Top applicants under product code SFC

Recent clearances under product code SFC

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