510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NJFClass II

Antibodies, Anti-Actin, Anti-Smooth Muscle

21 CFR 866.5120 / Immunology
FDA source (opens on fda.gov)

NJF is the FDA product code for Antibodies, Anti-Actin, Anti-Smooth Muscle, a class II device type, regulated under 21 CFR 866.5120. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NJF
Device name
Antibodies, Anti-Actin, Anti-Smooth Muscle
FDA definition
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.
Regulation
21 CFR 866.5120
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code NJF

By decision year
1 clearance under product code NJF with a decision year between 2002 and 2002, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NJF by decision year
YearClearances
20021

Applicants with the most clearances

Product code NJF
Applicants holding the most 510(k) clearances under product code NJF
ApplicantClearances
Inova Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code