510(k) K122945

STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 by Steritec Products Mfg Co, Inc. — Product Code JOJ

K122945 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg Co, Inc. for the device "STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126". The FDA issued a decision of Substantially Equivalent on April 30, 2013. The device falls under product code JOJ (Indicator, Physical/Chemical 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.