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FDA 510(k)

ANTITHYROID ANTIBODY IMMUNOFLUORESCENT

K-Number: K810982 · 1981-05-01

ApplicantImmuno-Products Industries
Decision Date1981-05-01
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTITHYROID ANTIBODY IMMUNOFLUORESCENT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Products Industries. It received FDA 510(k) clearance on 1981-05-01 under 510(k) number K810982. 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 ANTITHYROID ANTIBODY IMMUNOFLUORESCENT?

ANTITHYROID ANTIBODY IMMUNOFLUORESCENT is a medical device that received FDA 510(k) clearance on 1981-05-01. The listed applicant is Immuno-Products Industries. The 510(k) number is K810982.

When did ANTITHYROID ANTIBODY IMMUNOFLUORESCENT receive FDA 510(k) clearance?

ANTITHYROID ANTIBODY IMMUNOFLUORESCENT received FDA 510(k) clearance on 1981-05-01, under 510(k) number K810982.

Who is the listed applicant for ANTITHYROID ANTIBODY IMMUNOFLUORESCENT?

The FDA 510(k) record lists Immuno-Products Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTITHYROID ANTIBODY IMMUNOFLUORESCENT?

The FDA product code for ANTITHYROID ANTIBODY IMMUNOFLUORESCENT is JZO.

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Other records listing Immuno-Products Industries 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.

K853122IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPEDK852230ANA/LITE-RL TEST SYSTEMK852231ANA/LITE-HEP-2 TEST SYSTEMK843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBK831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUBK830652ANTI N DNA-HCP

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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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