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FDA 510(k)

125-I TSH RECEPTOR ANTIBODY KIT

K-Number: K863006 · 1986-09-08

ApplicantCronus
Decision Date1986-09-08
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

125-I TSH RECEPTOR ANTIBODY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cronus. It received FDA 510(k) clearance on 1986-09-08 under 510(k) number K863006. 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 125-I TSH RECEPTOR ANTIBODY KIT?

125-I TSH RECEPTOR ANTIBODY KIT is a medical device that received FDA 510(k) clearance on 1986-09-08. The listed applicant is Cronus. The 510(k) number is K863006.

When did 125-I TSH RECEPTOR ANTIBODY KIT receive FDA 510(k) clearance?

125-I TSH RECEPTOR ANTIBODY KIT received FDA 510(k) clearance on 1986-09-08, under 510(k) number K863006.

Who is the listed applicant for 125-I TSH RECEPTOR ANTIBODY KIT?

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

What is the FDA product code for 125-I TSH RECEPTOR ANTIBODY KIT?

The FDA product code for 125-I TSH RECEPTOR ANTIBODY 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 Cronus 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.

K871193I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KITK871194I-125 ANTI-MICROSOMAL ANTIBODY IRMA 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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