Cleared Traditional

Aptima HCV Quant Dx Assay

K233352 · Hologic, Inc. · Microbiology
Jul 2024
Decision
299d
Days
Class 2
Risk

About This 510(k) Submission

K233352 is an FDA 510(k) clearance for the Aptima HCV Quant Dx Assay, a Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus (Class II — Special Controls, product code MZP), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on July 24, 2024, 299 days after receiving the submission on September 29, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3170.

Submission Details

510(k) Number K233352 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date July 24, 2024
Days to Decision 299 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MZP — Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3170