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FDA 510(k)

KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT

K-Number: K915428 · 1992-03-30

ApplicantKronus
Decision Date1992-03-30
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kronus. It received FDA 510(k) clearance on 1992-03-30 under 510(k) number K915428. 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 KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT?

KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT is a medical device that received FDA 510(k) clearance on 1992-03-30. The listed applicant is Kronus. The 510(k) number is K915428.

When did KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT receive FDA 510(k) clearance?

KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT received FDA 510(k) clearance on 1992-03-30, under 510(k) number K915428.

Who is the listed applicant for KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA 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 KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT?

The FDA product code for KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA 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.

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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.

K915429KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KITK894203ANTI-THYROGLOBULIN TEST 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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