510(k) K152394

Rapicide PA High-Level Disinfectant Test Strips by Medivators, Inc. — Product Code JOJ

K152394 is an FDA 510(k) premarket notification submitted by Medivators, Inc. for the device "Rapicide PA High-Level Disinfectant Test Strips". The FDA issued a decision of Substantially Equivalent on March 11, 2016. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Medivators, Inc. has at least 10 other 510(k) clearances on record.