510(k) K081370

SERIM DISINTEK OPA TEST STRIP by Serim Research Corp. — Product Code JOJ

K081370 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM DISINTEK OPA TEST STRIP". The FDA issued a decision of Substantially Equivalent on July 11, 2008. 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.