Elecsys Anti-Tg— 510(k) K222610

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K222610 for Elecsys Anti-Tg, Substantially Equivalent on 2023-09-15. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2022-08-29
Decision date: 2023-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZO

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K240469 — Access TPO Antibody2024-08-09
K213517 — Access Thyroglobulin Antibody II2023-09-26
K193313 — Elecsys Anti-TSHR2020-02-27
K151799 — EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/50002016-03-25

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K260048 — Elecsys Anti-HAV IgM2026-04-07

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