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

Galectin-3 In Vitro Diagnostic Assay

21 CFR 862.1117 / Clinical Chemistry
FDA source (opens on fda.gov)

OSX is the FDA product code for Galectin-3 In Vitro Diagnostic Assay, a class II device type, regulated under 21 CFR 862.1117. FDA's definition for this code 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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OSX
Device name
Galectin-3 In Vitro Diagnostic Assay
FDA definition
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.
Regulation
21 CFR 862.1117
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code OSX

By decision year
2 clearances under product code OSX with a decision year between 2010 and 2014, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OSX by decision year
YearClearances
20101
20141

Applicants with the most clearances

Product code OSX
Applicants holding the most 510(k) clearances under product code OSX
ApplicantClearances
Bg Medicine, Inc.1
Fujirebio Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code