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

Name: FDA 510(k) clearance K221693
Creator: U.S. Food and Drug Administration
Published: 2023-01-04

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K221693 for Elecsys Anti-HCV II (08837031190), Substantially Equivalent on 2023-01-04. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code MZO
Device class: Class 2
Regulation: 21 CFR 866.3169
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 ↗

Recent devices under product code MZO

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K252424 — Anti-HCV Next2026-04-28

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K261686 — Elecsys Phospho-Tau (217P) Plasma2026-08-19
K252323 — cobas pulse blood glucose monitoring system2026-06-12
K252280 — Elecsys Anti-SARS-CoV-2 S2026-04-13
K260046 — Elecsys Anti-HBc II2026-04-07
K260048 — Elecsys Anti-HAV IgM2026-04-07

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.