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FDA 510(k)

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)

K-Number: K894364 · 1989-07-25

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

Device Summary

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) 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 K894364. 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 MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)?

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Kronus. The 510(k) number is K894364.

When did MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) receive FDA 510(k) clearance?

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) received FDA 510(k) clearance on 1989-07-25, under 510(k) number K894364.

Who is the listed applicant for MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)?

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 MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)?

The FDA product code for MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) 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 KITK894203ANTI-THYROGLOBULIN TEST KIT

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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