510(k) K060215

ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 by Eurotrol B.V. — Product Code JJX

K060215 is an FDA 510(k) premarket notification submitted by Eurotrol B.V. for the device "ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002". The FDA issued a decision of Substantially Equivalent on March 24, 2006. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Eurotrol B.V. has at least 6 other 510(k) clearances on record.