510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140224Substantially Equivalent

Euroimmun Euroline Ena Profile 9Ag (Igg)

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

K140224 is the FDA 510(k) clearance record for EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG), a class II device, cleared for Euroimmun US on under FDA product code LKO (Anti-Rnp Antibody, Antigen And Control). FDA records list 37 510(k) clearances for Euroimmun US, from to . As of , FDA records show no recalls naming K140224.

Clearance record

Decision date
Received
(314 days to decision)
Product code
LKO Anti-Rnp Antibody, Antigen And Control
Regulation
21 CFR 866.5100
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 LKO

Trailing 12 months

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

FDA records show no clearances under product code LKO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKO, 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