DeviceClearance

Product code LKO— Immunology

ANTI-ENA TEST

Classification name
Anti-Rnp Antibody, Antigen And Control
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Total cleared
23
First cleared
Most recent

Market context for product code LKO

FDA has cleared 23 devices under product code LKO between 1983 and 2019, filed by 18 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 LKO

Recent clearances under product code LKO

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