Andon Health's US subsidiary, 4-IN-1 Check and 3-IN-1 Check products, have received pre-market notification from the US FDA.

Andon Health (002432.SZ) announced that its US subsidiary, iHealth Labs Inc. (referred to as "iHealth US"), has received pre-market notifications from the US Food and Drug Administration (FDA) for the following products: 1. A four-in-one home test kit for the detection of influenza A, influenza B, COVID-19, and RSV respiratory syncytial virus; and a four-in-one professional test kit for the same viruses, both received FDA 510(K) pre-market notifications ("four-in-one test kit"). 2. A three-in-one home test kit for the detection of influenza A, influenza B, and COVID-19 viruses; and a three-in-one professional test kit for the same viruses, both received FDA 510(K) pre-market notifications ("three-in-one test kit"). After obtaining the pre-market notifications for the above products, they can be sold in the US market.