Tan Dem* - Ige Kit

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K802913 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

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

See all devices from Hybritech, Inc. →