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FDA 510(k)

ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA

K-Number: K925826 · 1993-01-26

ApplicantClark Laboratories, Inc.
Decision Date1993-01-26
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA is the device name listed in this FDA 510(k) record. The listed applicant is Clark Laboratories, Inc.. It received FDA 510(k) clearance on 1993-01-26 under 510(k) number K925826. 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 ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA?

ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA is a medical device that received FDA 510(k) clearance on 1993-01-26. The listed applicant is Clark Laboratories, Inc.. The 510(k) number is K925826.

When did ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA receive FDA 510(k) clearance?

ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA received FDA 510(k) clearance on 1993-01-26, under 510(k) number K925826.

Who is the listed applicant for ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA?

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

What is the FDA product code for ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA?

The FDA product code for ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA is JZO.

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Other records listing Clark Laboratories, 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.

K980912VCA IGG ELISA TEST SYSTEMK980596VCA IGM ELISA TEST SYSTEMK980598EBNA-1 IGM ELISA TEST SYSTEMK973123EA-D IGG ELISA TEST SYSTEMK931543ENCORE ENA COMBINED EIAK923537ENCORE DS-DNA

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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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