510(k) K251035

DISINTEK™ PA Test Strips by Serim Research — Product Code JOJ

K251035 is an FDA 510(k) premarket notification submitted by Serim Research for the device "DISINTEK™ PA Test Strips". The FDA issued a decision of Substantially Equivalent on June 3, 2025. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Serim Research has at least 10 other 510(k) clearances on record.