Tandem E Pap

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K851950 ↗

FDA Product Code

JFH

Device Class

Class II

Regulation

21 CFR Part 862.1020

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Tandem Icon II Hcg Immunoenzymetric Assay Kit

  Class II

  FDA 510(k) K860542 Active Cleared 5 Mar 1986

• Tandem-E Lh Immunoenzymetric Assay Kit

  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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