Gamma Slide Test for Infectious Mononucleosis

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K861016 ↗

FDA Product Code

KTN

Device Class

Class II

Regulation

21 CFR Part 866.5640

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Gamma Lewis Blood Group Substance

  Class II

  FDA 510(k) K802533 Active Cleared 12 Nov 1980

• Reagent, Lyophilized Anti-Streptolysin O

  Class I

  FDA 510(k) K760096 Active Cleared 3 Aug 1976

• Rst-Series Control

  Class II

  FDA 510(k) K800658 Active Cleared 16 Apr 1980

• Disposable Test Cards/Gamma Slide Test Infect Mono

  Class II

  FDA 510(k) K864207 Active Cleared 3 Dec 1986

• Gamma Pi Blood Group Substance

  Class II

  FDA 510(k) K802534 Active Cleared 12 Nov 1980

• Lo-Ion

  Class II

  FDA 510(k) K790973 Active Cleared 15 Jun 1979

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