510(k) K010534

CROSS-CHECKS DUAL, MODEL CI 125 by Steritec Products, Inc. — Product Code JOJ

K010534 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "CROSS-CHECKS DUAL, MODEL CI 125". The FDA issued a decision of Substantially Equivalent on August 6, 2001. 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.