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FDA 510(k)

NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY

K-Number: K983992 · 1999-01-26

ApplicantNichols Institute Diagnostics
Decision Date1999-01-26
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nichols Institute Diagnostics. It received FDA 510(k) clearance on 1999-01-26 under 510(k) number K983992. 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 NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY?

NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY is a medical device that received FDA 510(k) clearance on 1999-01-26. The listed applicant is Nichols Institute Diagnostics. The 510(k) number is K983992.

When did NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY receive FDA 510(k) clearance?

NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY received FDA 510(k) clearance on 1999-01-26, under 510(k) number K983992.

Who is the listed applicant for NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY?

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

What is the FDA product code for NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY?

The FDA product code for NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY is JZO.

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Other records listing Nichols Institute 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.

K050784NICHOLS ADVANTAGE ALDOSTERONE ASSAYK042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYK042689NICHOLS ADVANTAGE CORTISOLK040813NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYK033302NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

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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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