DeviceClearance

Product code JNL— Immunology

MICROSOMAL EIA TEST KIT

Classification name
Immunochemical, Thyroglobulin Autoantibody
Device class
Class 2
Regulation
21 CFR 866.5870
Advisory panel
Immunology
Total cleared
22
First cleared
Most recent

Market context for product code JNL

FDA has cleared 22 devices under product code JNL between 1990 and 2025, filed by 12 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

Top applicants under product code JNL

Recent clearances under product code JNL

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