510(k) K972035

SPOROX TEST STRIPS by Serim Research Corp. — Product Code JOJ

K972035 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SPOROX TEST STRIPS". The FDA issued a decision of Substantially Equivalent on August 29, 1997. 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.