510(k) K780889

DIGOXIN STANDARDS IN HUMAN SERUM by Pcl-Ria, Inc. — Product Code DMP

K780889 is an FDA 510(k) premarket notification submitted by Pcl-Ria, Inc. for the device "DIGOXIN STANDARDS IN HUMAN SERUM". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code DMP (Digoxin Control Serum, Ria), a Class I device regulated under 21 CFR 862.3280. Pcl-Ria, Inc. has at least 10 other 510(k) clearances on record.