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FDA 510(k)

TEST, (IVDP) THYROID ANTIBODY

K-Number: K760154 · 1976-07-20

ApplicantZeus Scientific, Inc.
Decision Date1976-07-20
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TEST, (IVDP) THYROID ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1976-07-20 under 510(k) number K760154. 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 TEST, (IVDP) THYROID ANTIBODY?

TEST, (IVDP) THYROID ANTIBODY is a medical device that received FDA 510(k) clearance on 1976-07-20. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K760154.

When did TEST, (IVDP) THYROID ANTIBODY receive FDA 510(k) clearance?

TEST, (IVDP) THYROID ANTIBODY received FDA 510(k) clearance on 1976-07-20, under 510(k) number K760154.

Who is the listed applicant for TEST, (IVDP) THYROID ANTIBODY?

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

What is the FDA product code for TEST, (IVDP) THYROID ANTIBODY?

The FDA product code for TEST, (IVDP) THYROID ANTIBODY is JZO.

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Other records listing Zeus Scientific, Inc. 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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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