510(k) K133322

STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR by Steritec Products Mfg Co, Inc. — Product Code FRC

K133322 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg Co, Inc. for the device "STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR". The FDA issued a decision of Substantially Equivalent on August 25, 2014. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products Mfg Co, Inc. has at least 10 other 510(k) clearances on record.