510(k) K844968

EPICHROME PAP by Cetus Corp. — Product Code JFH

K844968 is an FDA 510(k) premarket notification submitted by Cetus Corp. for the device "EPICHROME PAP". The FDA issued a decision of Substantially Equivalent on February 7, 1985. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Cetus Corp. has at least 2 other 510(k) clearances on record.