510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140436Substantially Equivalent

ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

Fujirebio Diagnostics, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140436 is the FDA 510(k) clearance record for ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS, a class II device, cleared for Fujirebio Diagnostics,Inc. on under FDA product code OSX (Galectin-3 In Vitro Diagnostic Assay). FDA's definition for product code OSX reads: "Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure". FDA records list 45 510(k) clearances for Fujirebio Diagnostics,Inc., from to . As of , FDA records show no recalls naming K140436.

Clearance record

Decision date
Received
(305 days to decision)
Product code
OSX Galectin-3 In Vitro Diagnostic Assay
Regulation
21 CFR 862.1117
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Fujirebio Diagnostics,Inc. 201 Great Valley Pkwy., Malvern PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OSX

Trailing 12 months

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

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