510(k) K220908

Ensol EnTM Specimen Collection and Transport System by Ensol Biosciences, Inc. — Product Code JSM

K220908 is an FDA 510(k) premarket notification submitted by Ensol Biosciences, Inc. for the device "Ensol EnTM Specimen Collection and Transport System". The FDA issued a decision of Substantially Equivalent on August 29, 2024. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390.