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FDA 510(k)

Elecsys Anti-Tg

K-Number: K222610 · 2023-09-15

ApplicantRoche Diagnostics
Decision Date2023-09-15
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys Anti-Tg is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K222610. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Anti-Tg?

Elecsys Anti-Tg is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Roche Diagnostics. The 510(k) number is K222610.

When did Elecsys Anti-Tg receive FDA 510(k) clearance?

Elecsys Anti-Tg received FDA 510(k) clearance on 2023-09-15, under 510(k) number K222610.

Who is the listed applicant for Elecsys Anti-Tg?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys Anti-Tg?

The FDA product code for Elecsys Anti-Tg is JZO.

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Related Devices (Code: JZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia ABK152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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