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FDA 510(k)

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME

K-Number: K930274 · 1993-02-23

ApplicantJoldon Diagnostics
Decision Date1993-02-23
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Joldon Diagnostics. It received FDA 510(k) clearance on 1993-02-23 under 510(k) number K930274. 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 THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME?

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME is a medical device that received FDA 510(k) clearance on 1993-02-23. The listed applicant is Joldon Diagnostics. The 510(k) number is K930274.

When did THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME receive FDA 510(k) clearance?

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME received FDA 510(k) clearance on 1993-02-23, under 510(k) number K930274.

Who is the listed applicant for THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME?

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

What is the FDA product code for THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME?

The FDA product code for THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME is JZO.

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Other records listing Joldon Diagnostics 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.

K925194THYROGLOBULIN AUTO-ANTIBODY EIA 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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