Research Use Only/Pathology
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Fujian.
What Is This Device?
For research use only and for products imported into the US only.
How Is OTU Classified?
Research Use Only/Pathology is FDA product code OTU, not classified.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Software design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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