Elecsys AFP— 510(k) K220176

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K220176 for Elecsys AFP, Substantially Equivalent on 2022-09-15. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LOJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2022-01-21
Decision date: 2022-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOJ

K213626 — VITROS AFP2022-06-15
K090236 — DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 64542009-04-27
K081709 — OLYMPUS AFP - ALPHA-FETOPROTEIN2009-03-16
K080017 — VIDAS AFP ASSAY2008-09-26
K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC6002008-06-04

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K260048 — Elecsys Anti-HAV IgM2026-04-07

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