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FDA 510(k)

Access Thyroglobulin Antibody II

K-Number: K213517 · 2023-09-26

ApplicantBeckman Coulter, Inc.
Decision Date2023-09-26
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Access Thyroglobulin Antibody II is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K213517. 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 Access Thyroglobulin Antibody II?

Access Thyroglobulin Antibody II is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K213517.

When did Access Thyroglobulin Antibody II receive FDA 510(k) clearance?

Access Thyroglobulin Antibody II received FDA 510(k) clearance on 2023-09-26, under 510(k) number K213517.

Who is the listed applicant for Access Thyroglobulin Antibody II?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Access Thyroglobulin Antibody II?

The FDA product code for Access Thyroglobulin Antibody II is JZO.

Other records listing Beckman Coulter, Inc. as applicant

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.

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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.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys 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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