Elecsys Anti-HCV II (08837031190)— 510(k) K221693

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K221693 for Elecsys Anti-HCV II (08837031190), Substantially Equivalent on 2023-01-04. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code MZO
Advisory panel: Microbiology
Date received: 2022-06-10
Decision date: 2023-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MZO

product code MZO

Malfunction: 466
Total: 466

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.