510(k) K003104

BACT/ALERT CSR by Organon Teknika Corp. — Product Code LJF

K003104 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "BACT/ALERT CSR". The FDA issued a decision of Substantially Equivalent on October 20, 2000. The device falls under product code LJF (Device, Antimicrobial Drug Removal), a Class I device regulated under 21 CFR 866.2560. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.