510(k) K990941

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L by Humagen Fertility Diagnostics, Inc. — Product Code MQK

K990941 is an FDA 510(k) premarket notification submitted by Humagen Fertility Diagnostics, Inc. for the device "NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L". The FDA issued a decision of Substantially Equivalent on July 14, 1999. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Humagen Fertility Diagnostics, Inc. has at least 4 other 510(k) clearances on record.