510(k) K894329

RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL by Amersham Corp. — Product Code JJX

K894329 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Amersham Corp. has at least 10 other 510(k) clearances on record.