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
K163177Substantially Equivalent

ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA

Immco Diagnostics, Inc., Clarence NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163177 is the FDA 510(k) clearance record for ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA, a class II device, cleared for Immco Diagnostics, Inc. on under FDA product code MST (Antibodies, Gliadin). FDA records list 55 510(k) clearances for Immco Diagnostics, Inc., from to . As of , FDA records show no recalls naming K163177.

Clearance record

Decision date
Received
(256 days to decision)
Product code
MST Antibodies, Gliadin
Regulation
21 CFR 866.5750
Device class
Class II
Review panel
Immunology
Applicant
Immco Diagnostics, Inc. 9870 Hollingson Rd., Clarence NY
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