510(k) K220778

Chemical Indicator for Steam by True Indicating, LLC — Product Code JOJ

K220778 is an FDA 510(k) premarket notification submitted by True Indicating, LLC for the device "Chemical Indicator for Steam". The FDA issued a decision of Substantially Equivalent on December 2, 2022. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. True Indicating, LLC has at least 5 other 510(k) clearances on record.