510(k) K241836

Kem Medical Lead-free Chemical Indicators for Steam Sterilization by Kem Medical Products Corporation — Product Code JOJ

K241836 is an FDA 510(k) premarket notification submitted by Kem Medical Products Corporation for the device "Kem Medical Lead-free Chemical Indicators for Steam Sterilization". The FDA issued a decision of Substantially Equivalent on September 30, 2024. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800.