510(k) K022352

HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) by <Genx> Intl., Inc. — Product Code MQL

K022352 is an FDA 510(k) premarket notification submitted by <Genx> Intl., Inc. for the device "HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)". The FDA issued a decision of Substantially Equivalent on August 28, 2002. 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 10 other 510(k) clearances on record.