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FDA 510(k)

THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY

K-Number: K083391 · 2009-05-21

ApplicantDiagnostic Hybrids, Inc.
Decision Date2009-05-21
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Hybrids, Inc.. It received FDA 510(k) clearance on 2009-05-21 under 510(k) number K083391. 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 STIMULATING IMMUNOGLOBULIN REPORTER ASSAY?

THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY is a medical device that received FDA 510(k) clearance on 2009-05-21. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K083391.

When did THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY receive FDA 510(k) clearance?

THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY received FDA 510(k) clearance on 2009-05-21, under 510(k) number K083391.

Who is the listed applicant for THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY?

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

What is the FDA product code for THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY?

The FDA product code for THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY is JZO.

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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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