510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093459Substantially Equivalent

Elia Gliadin Dp Iga Immunoassay and Elia Gliadin Dp Igg Immunoassay, Models 14-5538-01, 14-5539-01

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

K093459 is the FDA 510(k) clearance record for ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01, 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 2 recalls naming K093459.

Clearance record

Decision date
Received
(280 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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MST, 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