510(k) K000056

BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS by Biocell Laboratories, Inc. — Product Code JJX

K000056 is an FDA 510(k) premarket notification submitted by Biocell Laboratories, Inc. for the device "BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS". The FDA issued a decision of Substantially Equivalent on Feb 24, 2000. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Biocell Laboratories, Inc. has 5 other 510(k) clearances on record.