510(k) K991454

MOUSE IGG1 NEGATIVE CONTROLS by Dako Corp. — Product Code GKZ

K991454 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "MOUSE IGG1 NEGATIVE CONTROLS". The FDA issued a decision of Substantially Equivalent on June 21, 1999. 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.