NorLab
For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
Tonometer (Calibration and Q.C. Of Blood-Gas Instruments), Clinical
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Beijing.
- Beijing Hongdee Corporation Beijing
What Is FDA Product Code LCH?
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical is FDA product code LCH, Class 1, 21 CFR 862.1660.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Has Gone Wrong With It?
The FDA has recorded 2 recalls under this product code since 2002. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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