Tandem(R)-M Ferritin Immunoenzymetric Assay

• • Terminated Z-2096-2018 FDA Class II ·initiated 5 Mar 2018

  Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

510(k) Number

K863345 ↗

FDA Product Code

DBF

Device Class

Class II

Regulation

21 CFR Part 866.5340

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K860542 Active Cleared 5 Mar 1986

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  Class I

  FDA 510(k) K895094 Active Cleared 31 Oct 1989

• Tandem-E Thyroid Stimulating Hormone Kit

  Class II

  FDA 510(k) K832813 Active Cleared 31 Oct 1983

• TANDEM M-PAK PAP Immunoenzymetric Assay

  Class II

  FDA 510(k) K864945 Active Cleared 5 Jan 1987

• Tandem-E -Fer Immunoenzymetric Kit

  Class II

  FDA 510(k) K823871 Active Cleared 25 Feb 1983

• Photon Immunoassay Analyzer

  Class I

  FDA 510(k) K832364 Active Cleared 26 Aug 1983

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