510(k) K012811

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B by Humagen Fertility Diagnostics, Inc. — Product Code MQH

K012811 is an FDA 510(k) premarket notification submitted by Humagen Fertility Diagnostics, Inc. for the device "BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B". The FDA issued a decision of Substantially Equivalent on February 11, 2002. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Humagen Fertility Diagnostics, Inc. has at least 4 other 510(k) clearances on record.