510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063775Substantially Equivalent

Elia Gliadin Iga, Igg and Celiac Control

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

K063775 is the FDA 510(k) clearance record for ELIA GLIADIN IGA, IGG AND CELIAC CONTROL, a class II device, cleared for Phadia US, Inc. on under FDA product code MST (Antibodies, Gliadin). FDA records list 56 510(k) clearances for PHADIA AB, from to . As of , FDA records show no recalls naming K063775.

Clearance record

Decision date
Received
(83 days to decision)
Product code
MST Antibodies, Gliadin
Regulation
21 CFR 866.5750
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 MST

Trailing 12 months

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

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