510(k) K022643

BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 by Swemed Lab International AB — Product Code MQH

K022643 is an FDA 510(k) premarket notification submitted by Swemed Lab International AB for the device "BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540". The FDA issued a decision of Substantially Equivalent on November 5, 2002. The device falls under product code MQH (Microtools, Assisted Reproduction (Pipettes)), a Class II device regulated under 21 CFR 884.6130. Swemed Lab International AB has at least 3 other 510(k) clearances on record.