NJF · Class II · 21 CFR 866.5120

FDA Product Code NJF: Antibodies, Anti-actin, Anti-smooth Muscle

The Device Is Used For The Semi-quantitative Detection Of Igg Antibodies To The Actin Component Of Smooth Muscle In Human Serum As An Aid In The Diagnosis Of Certain Autoimmune Liver Diseases, E.g. Autoimmune Hepatitis.

Leading manufacturers include Inova Diagnostics, Inc..

Total

Cleared

123d

Avg days

2002

Since

FDA 510(k) Cleared Antibodies, Anti-actin, Anti-smooth Muscle Devices (Product Code NJF)

1 devices

1–1 of 1

Cleared Sep 20, 2002

QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA

K021648

Inova Diagnostics, Inc.

Immunology · 123d

About Product Code NJF - Regulatory Context

Related FDA 510(k) Regulatory Insights

What is a Predicate Device in FDA 510(k)?
What is an FDA Product Code?
What is 510(k) Clearance?
Browse all Immunology FDA 510(k) clearances
FDA 510(k) regulatory consulting firms ranked by submission volume
FDA 510(k) submission cost and user fees FY 2026

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Sep 20, 2002

Product Code Info

Code	NJF
Device class	Class II
CFR	21 CFR 866.5120
Panel	Immunology

Verify on FDA.gov

View NJF classification on FDA.gov →