510(k) K133549

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

K133549 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg Co, Inc. for the device "STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR". The FDA issued a decision of Substantially Equivalent on August 27, 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.