510(k) K181788

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

K181788 is an FDA 510(k) premarket notification submitted by Kem Medical Products Corp. for the device "Lead-free Chemical Indicators for Steam Sterilization". The FDA issued a decision of Substantially Equivalent on Mar 1, 2019. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Kem Medical Products Corp. has 2 other 510(k) clearances on record.