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FDA 510(k)

ANTI-THYROGLOBULIN TEST KIT

K-Number: K894203 · 1989-07-25

ApplicantKronus
Decision Date1989-07-25
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-THYROGLOBULIN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kronus. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K894203. 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 ANTI-THYROGLOBULIN TEST KIT?

ANTI-THYROGLOBULIN TEST KIT is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Kronus. The 510(k) number is K894203.

When did ANTI-THYROGLOBULIN TEST KIT receive FDA 510(k) clearance?

ANTI-THYROGLOBULIN TEST KIT received FDA 510(k) clearance on 1989-07-25, under 510(k) number K894203.

Who is the listed applicant for ANTI-THYROGLOBULIN TEST KIT?

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

What is the FDA product code for ANTI-THYROGLOBULIN TEST KIT?

The FDA product code for ANTI-THYROGLOBULIN TEST KIT is JZO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kronus 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.

K915428KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KITK915429KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KITK894364MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)

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.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 AB

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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