510(k) K191999

Sterilucent VH2O2 Chemical Indicators by Sterilucent, Inc. — Product Code JOJ

K191999 is an FDA 510(k) premarket notification submitted by Sterilucent, Inc. for the device "Sterilucent VH2O2 Chemical Indicators". The FDA issued a decision of Substantially Equivalent on October 21, 2019. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Sterilucent, Inc. has at least 6 other 510(k) clearances on record.