510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112221Substantially Equivalent

Euroimmun Anti-Sla/lp Elisa(lgg)

Euroimmun US Inc., Morris Plains NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112221 is the FDA 510(k) clearance record for EUROIMMUN ANTI-SLA/LP ELISA(LGG), a class II device, cleared for Euroimmun US on under FDA product code NIY (Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis). FDA's definition for product code NIY 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". FDA records list 37 510(k) clearances for Euroimmun US, from to . As of , FDA records show no recalls naming K112221.

Clearance record

Decision date
Received
(406 days to decision)
Product code
NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Euroimmun US 1100 The American Rd., Morris Plains NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NIY

Trailing 12 months

FDA records hold no clearances under product code NIY in the trailing twelve months.

FDA records show no clearances under product code NIY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NIY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260