510(k) K012221

SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM by Biosafe Laboratories, Inc. — Product Code JKA

K012221 is an FDA 510(k) premarket notification submitted by Biosafe Laboratories, Inc. for the device "SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 3, 2002. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Biosafe Laboratories, Inc. has at least 5 other 510(k) clearances on record.