Tandem-E -Ige Immunoezymetric Assay

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K823507 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  Class I

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• Tandem-E Thyroid Stimulating Hormone Kit

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• Tandem-E -Fer Immunoenzymetric Kit

  Class II

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• Photon Immunoassay Analyzer

  Class I

  FDA 510(k) K832364 Active Cleared 26 Aug 1983

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