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FDA 510(k)

AUTOSTAT ANTITHYROGLOBIN

K-Number: K925784 · 1993-01-21

ApplicantCogent Diagnotics , Ltd.
Decision Date1993-01-21
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOSTAT ANTITHYROGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Diagnotics , Ltd.. It received FDA 510(k) clearance on 1993-01-21 under 510(k) number K925784. 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 AUTOSTAT ANTITHYROGLOBIN?

AUTOSTAT ANTITHYROGLOBIN is a medical device that received FDA 510(k) clearance on 1993-01-21. The listed applicant is Cogent Diagnotics , Ltd.. The 510(k) number is K925784.

When did AUTOSTAT ANTITHYROGLOBIN receive FDA 510(k) clearance?

AUTOSTAT ANTITHYROGLOBIN received FDA 510(k) clearance on 1993-01-21, under 510(k) number K925784.

Who is the listed applicant for AUTOSTAT ANTITHYROGLOBIN?

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

What is the FDA product code for AUTOSTAT ANTITHYROGLOBIN?

The FDA product code for AUTOSTAT ANTITHYROGLOBIN is JZO.

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Other records listing Cogent Diagnotics , Ltd. 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.

K003057AUTOSTAT II ENA-4 PROFILE ELISAK003054AUTOSTAT II ENA-6 PROFILE ELISAK002215AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISAK993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISAK994338AUTOSTAT II RHEUMATOID FACTOR IGM ELISAK993085AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA

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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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