510(k) K092346

SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 by Serim Research Corp. — Product Code JOJ

K092346 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171". The FDA issued a decision of Substantially Equivalent on January 7, 2010. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Serim Research Corp. has at least 10 other 510(k) clearances on record.