510(k) K233352

Aptima HCV Quant Dx Assay by Hologic, Inc. — Product Code MZP

K233352 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Aptima HCV Quant Dx Assay". The FDA issued a decision of Substantially Equivalent on July 24, 2024. 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. Hologic, Inc. has at least 10 other 510(k) clearances on record.