Archive April 2017

510K Registration for Steam-SCBIs

gke got US FDA-registration for Steam-SCBIs

gke has received the 510(k) registration of the US american Food and Drug Administration (FDA) for their self-contained biological indicators (SCBI) for steam sterilization processes which will now be distributed in the US.

The self-contained biological indicators (SCBI) are used to monitor steam sterilization processes and are already sold into more than 50 countries by gke.