510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K082759Substantially Equivalent

Elia Cenp Immunoassay, Elia U1rnp Immunoassay, Elia Sm Immunoassay, Elia Ro Immunoassay

Phadia AB, Portage MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082759 is the FDA 510(k) clearance record for ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY, a class II device, cleared for Phadia US, Inc. on under FDA product code LKJ (Antinuclear Antibody, Antigen, Control). FDA records list 56 510(k) clearances for PHADIA AB, from to . As of , FDA records show no recalls naming K082759.

Clearance record

Decision date
Received
(200 days to decision)
Product code
LKJ Antinuclear Antibody, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Phadia US, Inc. 4169 Commercial Ave., Portage MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKJ

Trailing 12 months

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

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