510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140225Substantially Equivalent

Elia Pr3s Immunoassay, Elia Mpos Immunoassay, Elia Gbm Immunoassay, Elia Anca/gbm Positive Control 100, Elia Anca/gbm Po

Phadia AB, Freiburg Im Breisgau, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140225 is the FDA 510(k) clearance record for ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO, a class II device, cleared for Phadia US, Inc. on under FDA product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)). FDA records list 56 510(k) clearances for PHADIA AB, from to . As of , FDA records show one recall naming K140225.

Clearance record

Decision date
Received
(271 days to decision)
Product code
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Phadia US, Inc. Munzinger Strasse 7, Freiburg Im Breisgau, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOB

Trailing 12 months
1 clearance under product code MOB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MOB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260