510(k) K192503

GM501 Wash with Phenol Red and Gentamicin by Hamilton Thorne Incorporated — Product Code MQL

K192503 is an FDA 510(k) premarket notification submitted by Hamilton Thorne Incorporated for the device "GM501 Wash with Phenol Red and Gentamicin". The FDA issued a decision of Substantially Equivalent on Nov 19, 2020. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Hamilton Thorne Incorporated has 1 other 510(k) clearance on record.