DeviceClearance

Product code OYG— Clinical Chemistry

PRESAGE ST2 ASSAY

Classification name
St2 Assay
Device class
Class 2
Regulation
21 CFR 862.1117
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

FDA classification definition

“Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.”

— U.S. Food and Drug Administration, device classification record for product code OYG under 21 CFR 862.1117, via openFDA

Market context for product code OYG

FDA has cleared 1 device under product code OYG, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OYG

Recent clearances under product code OYG

Data sourced from openFDA. This site is unofficial and independent of the FDA.