K233352 is an FDA 510(k) clearance for the Aptima HCV Quant Dx Assay. This device is classified as 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 Diego, 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 FDA review panel. Regulated under 21 CFR 866.3170.
| 510(k) Number | K233352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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 |