510(k) K242107

CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) by Casebioscience, Inc. — Product Code MQL

K242107 is an FDA 510(k) premarket notification submitted by Casebioscience, Inc. for the device "CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)". The FDA issued a decision of Substantially Equivalent on March 21, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Casebioscience, Inc. has at least 1 other 510(k) clearance on record.