510(k) K252484

cobas HCV by Roche Molecular Systems, Inc. — Product Code MZP

K252484 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "cobas HCV". The FDA issued a decision of Substantially Equivalent on November 3, 2025. The device falls under product code MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus), a Class II device regulated under 21 CFR 866.3170. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.