Labware, Assisted Reproduction, Exempt

What Is This Device?

This product code is the class II exempt counterpart of MQK, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

What Is FDA Product Code PUD?

Labware, Assisted Reproduction, Exempt is FDA product code PUD, Class 2, 21 CFR 884.6160.

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.