DeviceClearance

Product code LJM— Immunology

ACCUTEX SLE LATEX TEST

Classification name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Total cleared
112
First cleared
Most recent

Market context for product code LJM

FDA has cleared 112 devices under product code LJM between 1982 and 2018, filed by 48 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 LJM

Recent clearances under product code LJM

1–100 of 112

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