510(k) K980635

DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 by Dako Corp. — Product Code GKZ

K980635 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37". The FDA issued a decision of Substantially Equivalent on July 22, 1998. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Dako Corp. has at least 10 other 510(k) clearances on record.