510(k) K080136

INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105 by Steritec Products, Inc. — Product Code JOJ

K080136 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105". The FDA issued a decision of Substantially Equivalent on August 15, 2008. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products, Inc. has at least 10 other 510(k) clearances on record.