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

Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

NIY is the FDA product code for Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis, a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code reads: "ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NIY
Device name
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
FDA definition
ELISA for the detection of anti-SLA (soluble liver antigen) antibody of the IgG class. Intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis
Regulation
21 CFR 866.5660
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
3
Ingested recalls
0

Clearances, product code NIY

By decision year
3 clearances under product code NIY with a decision year between 2002 and 2013, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NIY by decision year
YearClearances
20021
20121
20131

Applicants with the most clearances

Product code NIY
Applicants holding the most 510(k) clearances under product code NIY
ApplicantClearances
Euroimmun US Inc.2
Inova Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code