Access Thyroglobulin Antibody II— 510(k) K213517

Name: FDA 510(k) clearance K213517
Creator: U.S. Food and Drug Administration
Published: 2023-09-26

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K213517 for Access Thyroglobulin Antibody II, Substantially Equivalent on 2023-09-26. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 2021-11-03
Decision date: 2023-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZO

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K240469 — Access TPO Antibody2024-08-09
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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

More clearances from Beckman Coulter, Inc.

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K252169 — Access BNP II2026-03-24
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K251995 — Access anti-HAV IgM2026-01-27
K250588 — Access Rubella IgG2025-11-17

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