510(k) K250172

Green Card Bowie-Dick Test (BD115) by Steritec Products, Inc. (A Getinge Company) — Product Code JOJ

K250172 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. (A Getinge Company) for the device "Green Card Bowie-Dick Test (BD115)". The FDA issued a decision of Substantially Equivalent on February 20, 2025. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800.