510(k) K201213

Pasteur Pipette 3mL, Pasteur Pipette 1mL by Hertart Aps — Product Code MQK

K201213 is an FDA 510(k) premarket notification submitted by Hertart Aps for the device "Pasteur Pipette 3mL, Pasteur Pipette 1mL". The FDA issued a decision of Substantially Equivalent on December 16, 2020. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160.