K252102 is an FDA 510(k) clearance for the Alinity m HCV. 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 Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on September 25, 2025, 84 days after receiving the submission on July 3, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3170.
| 510(k) Number | K252102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2025 |
| Decision Date | September 25, 2025 |
| Days to Decision | 84 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 |