510(k) K083509

LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA by Genx Intl., Inc. — Product Code MQL

K083509 is an FDA 510(k) premarket notification submitted by Genx Intl., Inc. for the device "LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA". The FDA issued a decision of Substantially Equivalent on April 24, 2009. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Genx Intl., Inc. has at least 7 other 510(k) clearances on record.