Investigational Use Only – Hematology
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Shanghai.
- Infitek Co., Ltd. Shanghai
What Is This Device?
Investigational use only and for products imported into the US only.
What Is FDA Product Code PDC?
Investigational Use Only – Hematology is FDA product code PDC, not classified.
How Does It Reach the US Market?
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.
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