Detectadot System 2000 Heterophile Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K895891 ↗

FDA Product Code

KTN

Device Class

Class II

Regulation

21 CFR Part 866.5640

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Cmv Igm Elisa Test

  Class II

  FDA 510(k) K903807 Active Cleared 17 Dec 1990

• Detectadot System 2000 Toxo Igg Test

  Class II

  FDA 510(k) K875109 Active Cleared 7 Mar 1988

• Rubella Igg Elisa Test

  Class II

  FDA 510(k) K941624 Active Cleared 4 Aug 1995

• Anti-Respiratory Syncytial Virus Antibody Test

  Class I

  FDA 510(k) K882687 Active Cleared 30 Aug 1988

• Hsv 1+2 Igg Elisa Test

  Class II

  FDA 510(k) K983541 Active Cleared 26 Feb 1999

• Chagas' Igg Elisa Test

  Class I

  FDA 510(k) K911233 Active Cleared 4 May 1992

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