510(k) K001444

STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 by Steritec Products, Inc. — Product Code JOJ

K001444 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103". The FDA issued a decision of Substantially Equivalent on May 15, 2000. 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.