510(k) K994361

ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL by Genesis Industries, Inc. — Product Code MQK

K994361 is an FDA 510(k) premarket notification submitted by Genesis Industries, Inc. for the device "ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL". The FDA issued a decision of Substantially Equivalent on February 18, 2000. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Genesis Industries, Inc. has at least 10 other 510(k) clearances on record.