# Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262156 |
| Device | Anti-HCV Next |
| Applicant | Abbott Laboratories |
| Specialty / panel | Microbiology |
| Product code | MZO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-26 |
| Decision date | 2026-09-23 |
| Review time (days) | 89 |
| Third-party review | No |
| Applicant location | Abbott Park, IL, US |

## Why this score
- Fast 89-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262156). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.