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

St2 Assay

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

OYG is the FDA product code for St2 Assay, a class II device type, regulated under 21 CFR 862.1117. FDA's definition for this code reads: "Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
OYG
Device name
St2 Assay
FDA definition
Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
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
1
Ingested recalls
1

Clearances, product code OYG

By decision year
1 clearance under product code OYG with a decision year between 2011 and 2011, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OYG by decision year
YearClearances
20111

Applicants with the most clearances

Product code OYG
Applicants holding the most 510(k) clearances under product code OYG
ApplicantClearances
Critical Care Diagnostics, Inc. (dba Critical Diag1

Companies listing this code with FDA

Companies whose registered establishments list this code