DeviceClearance

Product code LKP— Immunology

AUTOSTAT II ANTI-SM ELISA

Classification name
Anti-Sm Antibody, Antigen And Control
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Total cleared
28
First cleared
Most recent

Market context for product code LKP

FDA has cleared 28 devices under product code LKP between 1984 and 2021, filed by 22 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 LKP

Recent clearances under product code LKP

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